Laparoscopic Vessel Sparing Descent of Intra-abdominal Testis: A Quasi-experimental Study.
Phase: NA
Conditions: Cryptorchidism
Sponsor: National Institute of Pediatrics, Mexico

 
 
 
 
 
 
 
 
 
 
 
 
Laparoscopic descent with preservation of testicular vessels for intra-
abdominal testis: A quasi-experimental study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Nov 23, 2024 - Version 3.0 - Protocol: "Laparoscopic descent with preservation of testicular vessels for intra-abdominal 
testis: Quasi-experimental study" for the Na;onal Ins;tute of Pediatrics. 
 
 
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Table of Contents 
 
Table of Contents 
Table of Contents ............................................................................................................ 2 
1.- Research Ques7on ..................................................................................................... 4 
2.-Summary: ................................................................................................................... 4 
3.- Theore7cal Framework: ............................................................................................. 6 
3.1. Introduc-on ..................................................................................................................... 6 
Embryology. ............................................................................................................................ 6 
3.3. Tes-cular Irriga-on ........................................................................................................... 8 
3.4. Classiﬁca-on ..................................................................................................................... 9 
3.5. Impact ............................................................................................................................ 10 
3.6. Consequences of cryptorchidism ..................................................................................... 11 
Malignancy .............................................................................................................................................. 11 
Fer/lity .................................................................................................................................................... 11 
3.6.3. Inguinal Hernia .............................................................................................................................. 11 
3.6.4. Tes/cular Torsion ........................................................................................................................... 12 
3.6.5. Other associated anomalies .......................................................................................................... 12 
3.7. Diagnosis ........................................................................................................................ 12 
3.8. Treatment ....................................................................................................................... 14 
4.- Problem Statement. ................................................................................................. 19 
5.- Jus7ﬁca7on .............................................................................................................. 20 
6.- Objec7ves ................................................................................................................ 21 
7.- Hypothesis ............................................................................................................... 22 
8.- Classiﬁca7on of the research. ................................................................................... 23 
9.- Material and Methods ............................................................................................. 24 
10. Flowchart ................................................................................................................ 30 
11. Sample size. ............................................................................................................ 31 
12. Deﬁni7on of Variables. ............................................................................................ 32 
13. Sta7s7cal Analysis. .................................................................................................. 33 
Ethical considera7ons. .................................................................................................. 34 
15.- Biosafety ................................................................................................................ 36 

 
 
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16Resources for research. ............................................................................................. 37 
17. Budget. ................................................................................................................... 38 
18Bibliography: ............................................................................................................ 40 
 
 
 
 

 
 
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1.- Research Ques6on 
 
 
What is the eﬃcacy and safety of laparoscopic tes3cular vessel-sparing techniques for 
intra-abdominal tes3cular descent? 
 
Hypothesis: 
 
• The VILO technique will be eﬀec<ve and safe, with a success rate of over 90% and 
the presence of tes<cular atrophy of less than 5%. 
 
• The Shehata technique will be eﬀec<ve and safe, with a success rate of over 90% 
and the presence of tes<cular atrophy of less than 5%. 
 
 
 
2.-Summary: 
Introduc3on: Cryptorchidism is the absence of one or both tes<cles in the scrotum; it is the 
most common congenital genital pathology iden<ﬁed at birth. The surgical treatment, 
orchidopexy, consists of reposi<oning the tes<cle in the scrotal pouch. Thirty percent of the 
cases correspond to "non-palpable tes<cles", which will require a diagnos<c laparoscopy, 
which is considered the treatment of choice for diagnosing and trea<ng these cases. A 
treatment is considered eﬀec<ve and safe when the tes<cle is able to descend into the 
scrotal sac without atrophy. The extreme scenario of cryptorchidism is intra-abdominal 
tes<cles with short tes<cular vessels, which makes primary descent impossible. For these 
cases, the technique proposed by Fowler-Stephens has been developed, which involves the 
sec<on of the tes<cular vessels so that in a second surgical stage, the descent can be 
achieved. This technique is not free of complica<ons; among the most frequent 
complica<ons is tes<cular atrophy. For this reason, the Shehata technique was developed, 
recently described in 2008, associated with a percentage of eﬃcacy and safety of 100%, with 
respect to scrotal descent without tes<cular atrophy, as long as a transopera<ve maneuver 
is performed to determine the length of the vascular pedicle, and consequently, the 
procedure to be performed (VILO vs. Shehata). However, there is not enough evidence to 
evaluate the relevance of this maneuver. 
 
 
 
Jus3ﬁca3on: Diagnosing and managing this pathology has evolved posi<vely in the last 50 
years. The extreme scenario corresponds to intra-abdominal tes<cles, where the length of 
the gonadal vessels is the limi<ng factor to achieve descent to the scrotum in a single 
surgical <me, without tension and without tes<cular atrophy 
 

 
 
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Laparoscopic techniques with preserva<on of tes<cular vessels could be the future for the 
correc<on of those pa<ents with intra-abdominal tes<cles. 
 
Research protocols are necessary to improve the future fer<lity of pa<ents through 
intrascrotal reposi<oning of the intra-abdominal tes<s. 
standardized and prospec<ve studies where the safety and eﬃcacy of tes<cular vessel 
sparing techniques can be evaluated to generate evidence for future decision making. 
 
Main objec3ves 
 
• To determine the safety and eﬃcacy of the laparoscopic Shehata technique for intra-
abdominal tes<cular descent. 
 
• To determine the safety and eﬃcacy of the laparoscopic VILO technique for intra-
abdominal tes<cular descent. 
 
Material and Methods: Pa<ents aged 6 months to 7 years, with intra-abdominal 
cryptorchidism corroborated by laparoscopy, non-syndromic, uni or bilateral, who, 
depending on the length of the tes<cular pedicle (without randomiza<on, quasi-
experimental study), will undergo a laparoscopic descent with preserva<on of tes<cular 
vessels, either a primary descent (VILO) or by the technique of elonga<on and delayed 
descent (Shehata). Six months a_er surgery, by means of ultrasonography and clinical 
examina<on, tes<cular atrophy (safety) and intrascrotal placement (eﬃcacy) will be 
determined, with the same subject being monitored before and a_er the opera<on 
 
 

 
 
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3.- Theore6cal Framework: 
3.1. Introduc-on 
 
Cryptorchidism comes from the Greek words kriptos, hidden/occult, and orchis, meaning 
tes<cle; the term "undescended tes<cle" is synonymous with cryptorchidism. The normal 
posi<on of the tes<cle is in the scrotum, in its middle third or below. Diagnosing and 
managing this pathology has evolved posi<vely in the last 50 years.  
 
Deﬁni3on: It is the absence of one or both tes<cles in their normal posi<on, represents the 
failure of tes<cular descent that do not reach their ﬁnal, intrascrotal posi<on(1) ; and is 
classiﬁed as congenital, if the tes<cle is outside the scrotum from birth. 
 
It is the most common congenital genital pathology iden<ﬁed at birth(1) , characterized by 
the absence of one or both tes<cles in the scrotal sac. It occurs in approximately 3% of term 
newborns and up to 30% in preterm pa<ents; most are not syndromic(3) . If cryptorchidism 
is not treated correctly, the repercussions can result in poten<al medium and long-term 
complica<ons in fer<lity issues(4, 5) , tes<cular cancer(6) , tes<cular torsion(7) , inguinal 
hernia(4) , and even psychological aspects(8) . The surgical treatment, orchidopexy, consists 
of reposi<oning the tes<cle inside the scrotal sac, in its middle third. Early correc<on is very 
important, as it signiﬁcantly improves the fer<lity of pa<ents(9) . There are diﬀerent severity 
spectrums, being the high intra-abdominal tes<cles, with very short tes<cular vessels that 
make the primary descent impossible, so they will require at least 2 surgeries to achieve the 
descent to the scrotum. 
 
The process of normal tes<cular descent has not been fully understood(2) , but any 
disrup<on will result in cryptorchidism, a spectrum with varying degrees of complexity and 
severity.  
 
Embryology. 
 
During weeks 6-7 of gesta<on, under the eﬀects of the SRY gene, the bipoten<al gonadal 
<ssue located in the genital ridge begins to diﬀeren<ate into tes<s. Under the inﬂuence of 
this gene, the cells of the medullary region form tes<cular epithelial cords in which Sertoli 
cells diﬀeren<ate in associa<on with primordial germ cells that migrate into these cords. 
Sertoli cell diﬀeren<a<on only occurs if the SRY protein is present. Otherwise, the sex cords 
would form ovarian follicles. These primi<ve tes<cular cords contain germ cells that 
eventually canalize and diﬀeren<ate into seminiferous tubules, in which sperm will be 
produced. Direct contact between developing Sertoli cells and primordial germ cells is 
thought to play a key role in the development of male gametes, an interac<on that occurs 
shortly a_er the arrival of primordial germ cells at the genital ridge. The tes<cular cords 
distal to the seminiferous tubules also develop lumina and diﬀeren<ate into a set of thin-
walled ducts called the rete tes's, just medial to the developing gonad. The tubules of the 

 
 
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rete tes<s connect with 5-12 residual mesonephric tubules that will form the eﬀerent ducts 
and transport the sperm to the head of the epididymis. The epididymis and vas deferens 
develop from the Wolﬃan duct.(10) 
 
As the developing Sertoli cells begin to diﬀeren<ate in response to the SRY protein, the 
secre<on of Müllerian inhibitory substance (MIS) also begins. MIS causes the 
paramesonephric (Müllerian) ducts to rapidly involute between the eighth and tenth week 
of gesta<on, leaving small tes<cular appendages that are nothing more than involuted 
Müllerian remnants, in addi<on to the prosta<c utricle. 
(10).  
 
In response to SRY protein during the 9th and 10th week of gesta<on, Leydig cells 
diﬀeren<ate from the mesenchymal cells of the genital ridge. These endocrine cells produce 
testosterone. In development, testosterone secre<on is regulated by placental chorionic 
gonadotropin, but fetal pituitary gonadotropins eventually take over control of androgen 
produc<on. Between weeks 8 to 12, testosterone secre<on from the Leydig cells s<mulates 
the mesonephric (Wolﬃan) ducts to transform into pairs of epididymis, vas deferens, and 
seminal vesicles, while the cranial por<ons of the mesonephric ducts degenerate, leaving a 
small cys<c remnant called the epididymal appendage. During week 9, 5 to 12 tubules make 
contact with the tes<cular network in the epididymal region. However, it is not un<l the 
third month that communica<on is established between the seminiferous tubules, the 
tes<cular network, the eﬀerent ducts, and the epididymis. In the mean<me, the 
mesonephric tubules near the lower pole of the tes<s degenerate, leaving epithelial 
remnants called paradidymis. (10) 
 
Gonadal descent 
 
Tes<cular descent occurs in 2 phases: transabdominal and transinguinal.  
 
The transabdominal phase occurs between 7 and 15 weeks of gesta<on(10) .  
Morphologically at 7 to 8 weeks of gesta<on, the urogenital ridge of humans is iden<cal in 
both sexes. Before gonadal diﬀeren<a<on, the tes<s is located near the developing kidney 
in the upper part of the lumbar region, akached by two ligaments: the cranial suspensory 
ligament (in the cephalic part) and the Gubernaculum in the caudal part. Between weeks 10 
to 15 during the enlargement of the abdominal cavity, the tes<cle descends to the inguinal 
region, thanks to the widening of the Gubernaculum and the involu<on of the cranial 
suspensory ligament(10) . Androgens are responsible for the involu<on of the cranial 
suspensory ligament. Gubernaculum widening occurs independently of androgen ac<vity, 
based on the fact that this occurs in androgen-resistant mice and humans. (10) 
 
From the seventh month, the gubernaculum prolapses beyond the external inguinal ring 
extending towards the scrotal region; simultaneously it is hollowed out by the diver<culum 
of the vaginal peritoneum, called "vaginal process". The vaginal process will allow the 

 
 
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passage of the intra-abdominal tes<s through the inguinal region and out of the abdominal 
cavity(10) . The inguinoscrotal descent requires the Gubernaculum to migrate a 
considerable distance, along with the increased length of the vaginal process. The force for 
migra<on comes from intra-abdominal pressure, transmiked directly and indirectly to the 
tes<s, through the lumen of the vaginal process and gubernacular cord respec<vely. (10) 
 
The second migratory step, the inguinoscrotal phase, is believed to be androgen-dependent. 
The transinguinal descent ends at 35 weeks of gesta<on. Androgens act indirectly through 
the genitofemoral nerve, which produces calcitonin gene-related pep<de (CGRP), to control 
the direc<on of tes<s migra<on(10) . Regression of the gubernacular bulb also appears to 
be androgen-dependent, since a_er comple<on of scrotal descent, the gubernaculum 
remains enlarged in humans with androgen resistance.  
 
Insulin-like/analogous pep<de 3 (INSL3) was iden<ﬁed as a novel gene product of Leydig 
cells. It is similar in structure to the pep<de hormones relaxin or insulin and is expressed in 
fetal and adult Leydig cells in a diﬀeren<a<on-dependent manner.  Mice lacking a func<onal 
INSL3 gene show intra-abdominal cryptorchidism but no obvious defects in other male 
reproduc<ve organs. More importantly, early surgical correc<on of cryptorchidism in these 
mice restores normal fer<lity poten<al. These ﬁndings are important because they reﬂect 
the phenotype most commonly observed in classic human cryptorchidism. (10) 
 
 
 
3.3. Tes-cular Irriga-on 
 
The arterial irriga<on of the tes<cle is condi<oned by 3 Arteries(11) : 1) the tes<cular artery, 
or gonadal artery, (of cephalic origin), 2) the deferen<al artery (from the vas deferens), and 
3) the cremasteric artery, or external sperma<c artery, as shown in Figure 1 .(11) 
 
 
Figure 1.  
 
The main arterial supply of the tes<s is provided by 1) the tes<cular artery (a. gonadal). The 
artery's origin comes directly from the abdominal aorta, immediately below the renal 
arteries, so its origin is cephalad to the internal inguinal oriﬁce. It then descends obliquely 
towards the internal inguinal oriﬁce, crosses the ureter and the psoas, enters the inguinal 
canal, and descends to the scrotum, ending at the posterior aspect of the tes<cle and 
epididymis. In its course, it gives branches to the ureter, the adipose capsule of the kidney, 
and the elements of the cord.  
 
2) The deferen<al artery originates from the inferior vesical artery, which, in turn, is a branch 
of the internal iliac or hypogastric artery. The deferen<al artery normally ascends together 
with the vas deferens, un<l it enters the internal inguinal oriﬁce, to descend together with 

 
 
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the rest of the elements of the cord un<l it reaches the posterior border of the tes<cle 
(normal anatomy). Normally, the deferen<al artery enters the internal inguinal oriﬁce 
forming an "ascending-descending loop" un<l it reaches the tes<cle normally implanted in 
the scrotum. The origin of the artery is caudal to the internal inguinal oriﬁce; therefore, in 
most cases, the length of this vessel is not a problem for tes<cular descent, which is why, as 
we will see below, the Fowler-Stephens technique uses it as the only ﬁnal irriga<on for 
tes<cular descent.  
 
3) The cremasteric artery originates from the inferior epigastric artery and supplies the 
cremasteric muscle, which is part of the cord elements.  
 
These 3 arteries are anastomosed near the tes<cle. There are anastomoses between the 
tes<cular vessels and the vas deferens; all pa<ents have good anastomoses between the 
tes<cular/gonadal and vas deferens arteries. There are also some anastomoses between 
these and the cremasteric arteries in approximately two-thirds pa<ents; addi<onal 
anastomoses appear to exist between the tes<cular, cremasteric and scrotal vessels.  
 
3.4. Classiﬁca-on 
 
The tes<cle is not a ﬁxed structure but presents a cephalic-caudal movement as a result of 
the cremasteric reﬂex and the contrac<on of the Dartos muscle, and it is a normal ﬁnding in 
all prepubertal boys. Also, the movement is a consequence of its posi<on within the 
peritoneal-vaginal process, mainly when it is located in the superﬁcial inguinal pouch, at the 
level of the external inguinal ring, in such a way that the tes<cle can move within the vaginal 
process. 
 
Based on the clinical examina<on, it is said to be a "palpable tes3cle" if, by means of a 
physical examina<on, with clinical maneuvers and without seda<on, it is possible to palpate 
and determine its posi<on, or it is a "non-palpable tes3cle" when it was impossible to locate 
it in the inguinal canal or in the scrotum; this is important, since the surgical approach to be 
followed will depend on this . (1) 
 
There are some en<<es to consider.  
Evanescent tes3cle: Ini<ally, there was the presence of a tes<cle, but in the development, 
it suﬀered some vascular accident, resul<ng in the loss of the tes<cle. During a laparoscopy, 
the pa<ent shows that at the conﬂuence of the deferens with the tes<cular artery, there is 
only an outline of gonadal vessels, without the existence of the tes<cle.(10)   
Tes3cular Agenesis: Refers to the fact that there has never been the forma<on of a tes<cle, 
with absence of sperma<c vessels and vas deferens, and therefore is associated with 
ipsilateral persistence of the Müllerian duct. (10) 
Congenital cryptorchidism: The absence of a tes<cle in the scrotum from birth.(10) 

 
 
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Acquired Cryptorchidism: A cryptorchid tes<cle that previously had a documented normal 
posi<on within the scrotum, but later, secondary to the individual's growth, the tes<cle 
ascended and is now palpable outside the scrotum.(2) 
Retrac3le tes3cles: Refers to those tes<cles that at the <me of examina<on are outside the 
scrotum but that can be located and that can easily descend into the scrotum and, when 
released from trac<on, remain in the scrotum.(1) 
Canicular tes3s: The tes<s is lodged in the inguinal canal, covered anteriorly by the 
aponeurosis of the external oblique muscle. The sperma<c vessels and the vas deferens 
enter the internal inguinal oriﬁce, with or without direct vision of the tes<cle.(10) 
Peeping" tes3cle refers to that intra-abdominal tes<cle lodged at the level of the internal 
inguinal ring, associated with a permeable vaginal peritoneal process, that as soon as CO2 
is insuﬄated into the abdominal cavity, the tes<cle moves towards the inguinal canal and it 
is when it is palpated externally, in the inguinal region. It is considered as intra-abdominal 
and the ideal is to manage it with a laparoscopic orchidopexy.(2) 
Intra-abdominal cryptorchidism: In this scenario, the tes<cles are located within the 
abdominal cavity or just inside the internal inguinal oriﬁce and are clinically not palpable. 
(10) 
 
Approximately 70% of cryptorchid tes<cles are palpable, the rest are "non-palpable," and 
more than 50% are intra-abdominal.(12, 13) 
 
3.5. Incidence 
 
Epidemiology: The incidence of cryptorchidism in preterm pa<ents weighing less than 2.5kg 
is 45% and decreases to 4.6% in term pa<ents weighing more than 2.5kg(14) . 80-85% of 
cases with cryptorchidism are isolated, i.e., they are NOT syndromic.(3) 
 
The incidence of cryptorchidism is 45% in preterm infants weighing less than 2.5kg and 
decreases to 4.6% in term infants weighing more than 2.5kg. The majority, 80-85%, of 
cryptorchidism is isolated, i.e., "non-syndromic cases." 
 
E3ology: There is no speciﬁc cause for cryptorchidism, being unknown in most cases, 
sugges<ng that it is a heterogeneous, mul<factorial pathology, with mul<ple risk factors, 
gene<c and environmental(3, 15) . Gene<cally, there is an associated component(16) ; a risk 
of 2.3 and 3.5 <mes higher probability of occurrence in children with family history(17) has 
been calculated. Among the environmental factors with estrogenic eﬀects or that interfere 
with androgen synthesis and ac<on. Exposure to pes<cides has been cited(18) seen in those 
mothers exposed to these agents as in agriculture, hor<culture, or in places with high 
pes<cide use. It has also been seen in those with exposure to diethyls<lbestrol(19) , pre-
eclampsia/eclampsia,(19, 20) , pre-gesta<onal and gesta<onal diabetes(19, 21) , 
smoking(22) , associated with consump<on of analgesics during gesta<on(23) , as well as 
advanced maternal age . (24) 
 

 
 
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3.6. Consequences of cryptorchidism 
 
The repercussions can result in poten<al medium and long term complica<ons in terms of: 
fer<lity(4, 5) , tes<cular cancer(6) , tes<cular torsion(7) , inguinal hernia(4) even 
psychological aspects(8) if it was not treated correctly. 
 
Malignancy 
 
In rela<on to the risk of tes<cular cancer, the inherent risk of malignant degenera<on of an 
undescended tes<cle is widely recognized, and the overall rela<ve risk of developing cancer 
for having presented cryptorchidism is 2.7 - 8 <mes(28) , 10% of adults with tes<cular cancer 
have a history of cryptorchidism(32) . A history of cryptorchidism increases the risk of 
developing tes<cular cancer by 2 to 8 <mes(25) ; it varies depending on its loca<on. It varies 
from 1% in inguinal tes<cles and 5% in intra-abdominal(26, 27) . Early correc<ons are 
associated with a decreased risk of developing cancer compared to those corrected a_er 
puberty(33, 34) . Evidence indicates that it decreases when corrected before puberty, 
represen<ng a 2 - 6-fold reduc<on in rela<ve risk compared to postpubertal orchidopexy. Of 
the neoplasms, seminomas are the most frequent in intra-abdominal cryptorchidism(28, 29) 
and non-seminomas in those who have undergone successful orchidopexy.(30, 31) 
 
 
Fer-lity 
 
It has been demonstrated that the aﬀecta<on of fer<lity in pa<ents with a history of 
cryptorchidism is present in variable degrees, being more aﬀected those cases of bilaterality, 
intra-abdominal tes<cles, as well as those operated late. Thus, the current trend is to correct 
the problem before 12 months of age.(35) 
 
Uncorrected testes, par<cularly those that are not palpable, are at increased risk for ongoing 
germ cell and Leydig cell loss(36) ; the dura<on of this condi<on correlates with higher rates 
of germ cell loss and infer<lity in adulthood(37-39) , as well as more tes<cular ﬁbrosis(40, 
41) . These histological changes are associated with abnormal semen parameters in 
adulthood(42, 43) , sugges<ng that cryptorchidism is a progressive disease rather than a 
sta<c congenital malforma<on.(44) 
 
3.6.3. Inguinal Hernia 
 
The presence of a permeable vaginal peritoneal process is very variable, it is present in 20-
73% of the cases(45, 46) , even, there are works in which they have found the presence of 
a permeable vaginal peritoneal process with altera<ons in the deferens, independently of 
the posi<on of the tes<cle(47) . An open internal inguinal ring is an area of weakness of the 
pelvic ﬂoor, which predisposes to the development of an inguinal hernia; for these reasons, 

 
 
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at the <me of cryptorchidism correc<on, a permeable vaginal peritoneal process must be 
closed. 
 
3.6.4. Tes-cular Torsion 
 
Tes<cular torsion can occur in pa<ents with cryptorchidism, who do not have a normal 
tes<cular descent and therefore have a poor ﬁxa<on of the Gubernaculum, the normal distal 
ﬁxa<on element, so they have a higher risk of suﬀering a tes<cular torsion(7) ; so 
orchidopexy also prevents this poten<al and catastrophic complica<on. 
 
 
3.6.5. Other associated anomalies 
 
Pa<ents with cryptorchidism present other altera<ons that interfere with their future 
reproduc<ve capacity. Among these, we have defects of the junc<on of the epididymis with 
the tes<s, present in 16-75%(48) .  These anomalies correlate with the degree of severity of 
cryptorchidism and the degree of permeable peritoneo-vaginal process(47) , being more 
frequent the complete separa<on of the epididymis from the tes<cle in those intra-
abdominal(49) . All these epididymal abnormali<es poten<ally contribute to subfer<lity in 
pa<ents with a history of cryptorchidism. 
 
3.7. Diagnosis 
 
The diagnosis of cryptorchidism is made by genital physical examina<on in a warm 
environment. Infants are examined in the supine posi<on, with the legs in the frog posi<on, 
beginning with inspec<on of the shape, size, colora<on and grooves of the scrotal pouch, 
the presence or absence of enlargement at the inguinal level, the size of the penis and the 
presence of deformi<es of the urethral meatus. With one hand, gentle downward pressure 
is applied along the inguinal canal. On the other hand, the aﬀected tes<cle is explored, as 
well as the contralateral tes<cle. In pa<ents with monorchidism, it is common to ﬁnd the 
presence of compensatory hypertrophy. A hypoplas<c scrotum implies that the tes<cle is 
not present inside the scrotum. It is important to correctly classify cryptorchidism as 
palpable and non-palpable tes7cle, as it will determine the surgical approach (See Figure 
2)(1) . A "non-palpable tes<cle" is a clear indica<on for surgical explora<on.(50) 
 
Clinical prac<ce guidelines indicate that prior to referral of the pa<ent to the surgeon, it is 
not necessary to perform diagnos<c imaging studies(1) since, in experienced hands, 70% of 
the testes correspond to "palpable testes" and the remaining 30% to non-palpable testes. 
Ultrasound has a sensi<vity and speciﬁcity for localizing non-palpable testes of 45% and 
78%, respec<vely(51) ; this study accurately determine the presence or absence of an 
evanescent tes<s. Regarding computed axial tomography, it is a study with ionizing radia<on 
and is, therefore, not indicated as a diagnos<c study for a non-palpable tes<cle in the 

 
 
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13 
pediatric popula<on. Regarding Nuclear Magne<c Resonance Imaging, it requires general 
anesthesia to perform it(52-56) and it is not available in all centers; so that a non-palpable 
tes<cle is an indica<on to perform a surgical explora<on, since no imaging study can 
conclude with 100% certainty the absence or presence of tes<cle (evanescent tes<cle).  
 
Clinical prac<ce guidelines indicate that all newborns with a history of cryptorchidism 
detected at birth, and those who have not spontaneously descended during the ﬁrst 6 
months of life (corrected for gesta<onal age), should be referred to a surgeon for a <mely 
evalua<on(50, 57) . Because a_er 6 months, the probability of spontaneous descent is very 
low, and histological damage to the tes<s outside the scrotum con<nues. The results of a 
clinical trial in which early correc<on was performed at 9 months of age vs. 3 years of age 
showed beker tes<cular growth in those pa<ents operated on early .(9) 
 
Figure 2.  
 
 
 
 
In prepubertal pa<ents with undescended tes<cles in whom conven<onal clinical 
examina<on fails to palpate the tes<cle, an examina<on under anesthesia should be 
performed to determine exactly whether the tes<cle is palpable or not(1) . Of these 
pa<ents, up to 18% can be palpated under anesthesia(58) . If palpa<on is achieved, open 
orchidopexy is performed through an inguinal, scrotal, or mixed approach. In those where 
palpa<on was not achieved, abdominal explora<on should be performed either 
laparoscopically or by open surgery. (1) 
 
Laparoscopic surgery is the method of choice for a non-palpable tes<s(58, 59) . It allows the 
surgeon to inspect the retroperitoneum with minimal morbidity and perform a thorough 
search along the path of the normal embryologic descent, which runs perineal to the 
internal inguinal foramen. 
 
We have 4 clinical scenarios that can be encountered during laparoscopy.  
 
1) The deferens and tes<cular vessels are observed entering the closed internal inguinal 
oriﬁce, indica<ng that the tes<cle is in the inguinal canal. Therefore, the procedure should 
be con<nued with an open inguinal explora<on to perform the orchidopexy, a scenario that 
occurs in up to 34% of cases.(58) 
 
2) You ﬁnd an evanescent tes3cle. Laparoscopically, the conﬂuence of the vas deferens and 
sperma<c vessels is observed, but there is no tes<cle, so surgical treatment is concluded.  
 
3) If you ﬁnd a hypoplas3c or dysgenesis tes3cle, the procedure will consist of removing it, 
as long as the contralateral tes<cle is located in the scrotum and has a good volume.  

 
 
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4) You ﬁnd the tes<cle not dysgenesis, of good size.  In this case, a laparoscopic orchidopexy 
is performed. The technique for descent is currently strongly inﬂuenced by the surgeon's 
preference. However, the main factor should be the length of the tes<cular vessels. If the 
length of the tes<cular vessels allows it, a primary orchidopexy (VILO) is performed, but in 
case the tes<cular vessels are very short and do not allow descent into the scrotum, an 
orchidopexy is performed with the Fowler-Stephens technique or according to the Shehata 
technique. Thus, the main limita<on to performing a primary orchidopexy is the length of 
the vascular pedicle. 
 
With this we conclude that a laparoscopy has 2 func<ons: 1) diagnos<c, i.e., it locates the 
non-palpable tes<cle, 2) therapeu<c, as a minimally invasive method to perform an 
orchidopexy. 
 
3.8. Treatment 
 
Indica3ons and surgical 3me. 
 
The main reasons for managing cryptorchidism are the increased risk of poten<al fer<lity 
impairment, tes<cular malignancy, tes<cular torsion, and associated inguinal hernia. 
Successful orchidopexy may reduce but not prevent possible long-term sequelae in 
suscep<ble individuals.  
 
Uncorrected testes, par<cularly those that are not palpable, are at increased risk for 
con<nued germ cell and Leydig cell loss(36) .  The dura<on of this condi<on correlates with 
increased germ cell losses, infer<lity in adulthood(37-39) , and increased tes<cular 
ﬁbrosis(40, 41) . These histological changes are associated with abnormal semen 
parameters in these pa<ents in adulthood(42, 43) , sugges<ng that cryptorchidism is a 
progressive disease, not a sta<c congenital malforma<on.(44) 
 
The current recommenda<on is that pa<ents 6 months of age who persist with 
cryptorchidism should be corrected within the next 12 months(59, 60) , although the trend 
is towards correc<on during the ﬁrst year of life, as it favors tes<cular growth and decreases 
histological damage.(35, 61) 
 
 
Medical Management: 
 
Hormonal therapies have been associated with side eﬀects, so they are not recommended 
to s<mulate tes<cular descent as a treatment for cryptorchidism in boys.(1, 50) 
 

 
 
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Medical treatment has limited beneﬁts, which have not been signiﬁcantly posi<ve. Studies 
indicate that Luteinizing Hormone-Releasing Hormone (LHRH) therapy is marginally more 
eﬀec<ve than placebo.   
 
Other uses of Human Chorionic Gonadotropin Hormone (hCG), include treatment of 
acquired cryptorchidism and improving "palpability" and treatment of abdominal 
tes<cles(62, 63) 
 
Human Chorionic Gonadotropin Hormone (HCG) s<mulates androgen produc<on through 
Leydig cell ac<vity. Its ac<on is virtually iden<cal to pituitary LH ac<vity. Its use oﬀers limited 
eﬃcacy. Studies have not shown long-term eﬃcacy, with a high risk of recurrence. Adverse 
eﬀects occur in up to 75% of children. They include increased scrotal folds, scrotal 
hyperpigmenta<on, appearance of pubic hair, and penile growth. A total dose higher than 
15,000 IU of HCG should be avoided as it may induce epiphyseal plate fusion and soma<c 
growth retarda<on.(64) 
 
The 
recognized 
side 
eﬀects 
of 
Luteinizing 
Hormone 
Releasing 
Hormone 
(LHRH)/Gonadotropin Releasing Hormone (GnRH) therapy are less frequent than those 
observed with HCG. There is no long-term evalua<on of LHRH treatment. As for HCG and 
GnRH, it has been reported that hormone treatment can damage germ cells in 1-3-year-old 
boys who did not respond to hormone treatment used to induce tes<cular descent.(65) 
 
GnRH = Gonadotropin-releasing Hormone 
FSH= Follicle S<mula<ng Hormone 
LH= Luteinizing Hormone 
LHRH = Luteinizing Hormone Releasing Hormone 
 
Surgical Management 
 
An eﬀec<ve and safe surgical treatment is deﬁned as tes<cular reposi<oning in the scrotal 
sac (eﬃcacy), without tes<cular atrophy (safety).(61) 
 
The anatomical success rate in expert hands is 74% for abdominal testes, 82% for peeping 
testes, 87% for canalicular testes, and 92% for testes below the external inguinal ring(66) . 
The percentage of tes<cular atrophy is 3.3%, 6.9%, and 18.5% for testes in suprascrotal, 
canalicular (inguinal), and above the internal inguinal oriﬁce posi<ons, respec<vely.(67) 
 
For those in which palpa<on is achieved, an inguinal or transscrotal orchidopexy is 
performed(60, 61) or by a mixed approach.  
 
Diagnos3c and therapeu3c laparoscopy for the non-palpable tes3cle:  
 

 
 
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As men<oned, 70% of undescended testes are palpable on physical examina<on, not 
requiring at least imaging for diagnosis. The remaining 30% correspond to non-palpable 
tes<cles, where the challenge is to conﬁrm the absence or presence of the non-palpable 
tes<cle, and to determine its loca<on and characteris<cs. 
 
If during diagnos<c laparoscopy a non-dysgenic intra-abdominal tes<cle of good volume is 
found, it is corrected. Depending on the length of its gonadal vessels, any of the following 3 
surgical treatments are performed: 
 
1) Serial orchidopexy with the Fowler-Stephens (FS) technique in 2 stages 
2) Vessel-preserving laparoscopic primary laparoscopic orchiopexy (Vessel Intact 
Laparoscopic Orchiopexy) VILO 
3) 2-stage gonadal vessel-preserving serial laparoscopic trac<on orchidopexy 
(Shehata). (68, 69) 
 
Thus, we can classify VILO and Shehata as laparoscopic techniques that preserve tes<cular 
vessels and the Fowler Stephens technique as the technique that involves the sec<on of 
tes<cular vessels. Each of these techniques is detailed below: 
 
1) Fowler-Stephens (FS): The method described in 1959(70) consists of cupng the 
gonadal vessels (tes<cular artery and vein) to allow the descent to the scrotum 
without tension so that the irriga<on of the tes<cle will be only in charge of the 
deferen<al artery (Figure 3). Once the gonadal vessels are cut, it is expected to 
develop collateral irriga<on and hypertrophy of the deferen<al artery so that, 6 
months later in a second surgical <me, it can be descended to the scrotum, 
without the limita<on imposed by the short gonadal vessels that prevented its 
primary descent without tension. This method is limited to cases where the 
gonadal/tes<cular vessels are too short to allow descent into the scrotum 
without tension. However, it has been shown that there is a decrease in germ 
cells a_er sec<oning the gonadal vessels.(71, 72) 
 
Figure 3.  
 
 
2) VILO (vessel sparing primary laparoscopic orchidopexy): This technique is only 
useful for pa<ents with suﬃcient length of the vascular pedicle and deferens 
length to achieve descent of the tes<s in a single surgical <me. The determina<on 
of suﬃcient length is considered if the tes<cle reaches the contralateral internal 
inguinal foramen without tension, as described in the ﬁgure(69) .  For pa<ents 
who do not have such length, the Shehata technique should be performed 
(Figure 1). Descending a tes<cle with a short vascular pedicle will ul<mately 
result in the tes<cle being in a subop<mal posi<on (suprascrotal), or with 
excessive tension that could result in tes<cular atrophy or recurrence of 

 
 
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cryptorchidism. In this technique, only the Gubernaculum is cut; the en<re 
tes<cle is detached with the mesentery created with its gonadal vessels, the 
deferens, and its deferen<al artery(73) . A_er sec<oning the Gubernaculum 
ligament, the peritoneum lateral to the gonadal vessels is cut and bluntly 
dissected, as well as the peritoneum covering the deferens, up to the supra 
vesical por<on, detaching the tes<cle with all this peritoneal ﬂap that includes 
the gonadal vessels and the deferens with its irriga<on, making the tes<cle intra-
abdominal reach the contralateral inguinal oriﬁce making the dissected tes<cular 
pedicle touch the anterior abdominal wall (Figure 5). If such mobiliza<on is 
achieved, it would theore<cally have the necessary length to descend the tes<cle 
to the scrotum, through a paravesical neotray and medial to the ipsilateral 
inguinal ligament, which is shorter compared to the physiological trajectory of 
the inguinal canal. 
 
3) Shehata: This technique is ONLY reserved for those tes<cles that have a short 
vascular pedicle, which prevents the primary descent into the scrotum without 
tension (Figure 5). This technique performs the same steps as VILO, ie: preserves 
the irriga<on of the gonadal vessels and the irriga<on of the deferens, but lacking 
suﬃcient length, the tes<s is temporarily ﬁxed above the contralateral iliac crest, 
deferring descent into the scrotum for 12 weeks, wai<ng for the mesentery of 
the tes<cle (tes<cular artery, deferens and deferen<al artery) to elongate, with 
the abdominal movements of the pa<ent and intes<nal distension, so that in a 
second laparoscopic surgical <me, it can be descended to the scrotum via the 
paravesical route. This technique has recently been described(68) , with the 
advantages of oﬀering a superior length to that obtained by VILO while 
preserving the main irriga<on of the tes<cle.  
 
Figure 4.  
 
The original FS approach was described as a single-stage open inguinal approach(70) . This 
one-stage approach resulted in severe hypoperfusion to the tes<cle, which was associated 
with a high rate of tes<cular atrophy of up to 32%(74) . This led to doing it in 2 stages(75) , 
decreasing tes<cular atrophy by 13%(76) and, in the best cases, by 6%(77) . The anatomical 
success of FS in terms of intrascrotal posi<on is 83%.(78) 
 
As for VILO, tes<cular atrophy has been reported to be greater than 5%(79, 80) . 
Preserva<on of tes<cular irriga<on will always be preferred; however, many <mes before 
sec<oning the Gubernaculum, it is technically diﬃcult to determine if the ﬁnal length of the 
mesentery of the vascular pedicle will be suﬃcient to achieve descent in a single <me, which 
has led to subop<mal anatomical results with this technique in terms of reaching the 
posi<on within the scrotum without tension(81) . The descent should be performed without 
tension to avoid retrac<on and hypoperfusion.(82) 
 

 
 
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At this <me, there is no objec<ve way to measure the necessary length of the vascular 
pedicle to achieve tension-free tes<cular descent. Some "indirect" trans-opera<ve 
maneuvers have been described to predict whether the length of the vascular pedicle will 
be suﬃcient to descend the tes<cle into the scrotum without tension. Among them, there 
is the belief that if the aﬀected tes<cle reaches to touch the contralateral internal inguinal 
foramen, it will be suﬃcient(83) . Another maneuver is the same, except that at the same 
<me, the middle third of the pedicle should touch the abdominal wall, a maneuver 
described by Shehata(69) (Figure 5). It has also been said that if the tes<cle is more than 
2cm away from the internal inguinal oriﬁce, it is a candidate to perform a Fowler-Stephens 
descent(84) . Thus, up to this point, the issue of an objec<ve measurement of the vascular 
pedicle has not been clariﬁed. 
 
Figure 5 
 
Thus, those who do not achieve suﬃcient length should ideally undergo an orchidopexy 
with Shehata's principles, temporarily pexing the tes<cle on the contralateral side, above 
the iliac crest, so that 12 weeks later in a 2nd surgical <me, the orchidopexy is completed, 
already with suﬃcient and appropriate length and irriga<on. In such a way, that in a second 
<me it cannot be considered a control ***** The original report by Shehata reported to be 
eﬀec<ve and safe in terms of anatomical success of 100% (eﬃcacy), without tes<cular 
atrophy (safety).(85) 
 
The ﬁnal results of the surgery are evaluated 6 months a_er surgery, without <ssue 
inﬂamma<on, allowing the evalua<on of the anatomical success (ﬁnal tes<cular posi<on), 
viability, and tes<cular size. (79, 85) 
 
In the INP, tradi<onally, the Fowler-Stephens technique has been performed. Personally, we 
have pa<ents who have presented tes<cular atrophy a_er a Fowler-Stephens procedure. 
This has led me to look for another alterna<ve to have beker results, and in recent months, 
several pa<ents have been operated on with this technique. So far, with good results, except 
for 2 pa<ents who had to be operated on again because the tes<cle in the lapse of the 1st 
and 2nd surgery was detached intra-abdominally, so the length was not op<mal for the ﬁnal 
descent. I have also performed VILO. However, the limita<on is that not all pa<ents have 
suﬃcient length to perform the primary descent.  I believe that it is necessary to implement 
and document what we are doing. 
 
Prospec<ve registries and standardized protocols are required to inves<gate the risks of 
tes<cular atrophy and address safety concerns associated with orchidopexy techniques. 
 
 

 
 
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4.- Problem Statement. 
 
Cryptorchidism is the most common congenital genital pathology iden<ﬁed at birth, 
characterized by the absence of one or both tes<cles in the scrotal sac. It occurs in 
approximately 3% of term newborns and up to 30% in preterm pa<ents, most of whom are 
not syndromic. The repercussions can result in poten<al medium and long-term 
complica<ons such as fer<lity issues, tes<cular cancer, tes<cular torsion, inguinal hernia, 
and even psychological aspects if cryptorchidism is not treated correctly. The treatment is 
surgical correc<on (orchidopexy), which consists of reposi<oning the tes<cle inside the 
scrotal pouch.) 70% of cryptorchidism are "palpable tes<cles" which are repaired openly, 
but 30% of the cases correspond to "NON palpable tes<cles", which require diagnos<c and 
possibly therapeu<c laparoscopy.  
 
Laparoscopic techniques with preserva<on of tes<cular vessels (Shehata and VILO) allow 
the intra-abdominal tes<cles to descend to the scrotal sac. This has the advantage of not 
sec<oning the main irriga<on of the tes<cles, which would have a posi<ve impact on the 
future fer<lity of the pa<ents. 
 
 
 
 

 
 
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5.- Jus6ﬁca6on 
 
 
The diagnosis and management of this pathology have evolved posi<vely in the last 50 
years. The most extreme scenario corresponds to intra-abdominal tes<cles, where the 
length of the gonadal vessels is the limi<ng factor in achieving their descent to the scrotum 
in a single surgical <me without tension and without tes<cular atrophy. 
 
The laparoscopic technique with preserva<on of tes<cular vessels could be the future for 
the correc<on of those pa<ents with intra-abdominal tes<cles. 
 
Intrascrotal reposi<oning of the intra-abdominal tes<s will be essen<al to improving the 
future fer<lity of these pa<ents, so standardized and prospec<ve research protocols are 
necessary to evaluate the safety and eﬃcacy of tes<cular vessel preserva<on techniques 
and generate evidence that will be useful for future decision-making.  
 
 
 
 
 
 
 
 
 
 
 

 
 
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6.- Objec6ves 
 
Primary objec3ve: 
 
• To determine the safety and eﬃcacy of the laparoscopic Shehata technique for intra-
abdominal tes<cular descent. 
 
• To determine the safety and eﬃcacy of the laparoscopic VILO technique for intra-
abdominal tes<cular descent. 
 
 
 

 
 
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7.- Hypothesis 
 
 
• The VILO technique will be eﬀec<ve and safe, with a success rate of over 90% and 
the presence of tes<cular atrophy of less than 5%. 
 
• The Shehata technique will be eﬀec<ve and safe, with a success rate of over 90% 
and the presence of tes<cular atrophy of less than 5%. 
 
 
 
 
 

 
 
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8.- Classiﬁca6on of the research. 
 
 
 
This is a quasi-experimental before-and-a_er study. It does not have a control group, being 
the same subject the control before and a_er the interven<on, without random 
assignment. 
 
Study: quasi-experimental (analytical, experimental, prospective, and longitudinal). 
 
Sampling: Non-probabilis<c sampling 
 
 
 
 
 
 
 

 
 
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9.- Material and Methods 
 
Target popula3on: boys with non-syndromic cryptorchidism, uni- or bilateral. 
 
Eligible popula3on: Children with non-palpable tes<cle between 6 and 7 years old who 
are treated at the INP without previous treatment. 
 
Inclusion criteria 
• Pa<ents with non-syndromic intra-abdominal cryptorchidism were corroborated by 
laparoscopy.  
• Pa<ents whose parents or guardians sign an informed consent form for their 
inclusion. 
• Pa<ents belonging to Mexico City or nearby areas who can akend the follow-up. 
 
Exclusion Criteria: 
• Pa<ents with other concomitant genital anomalies (e.g., hypospadias). 
 
 
 
Elimina3on Criteria:  
• Boys with non-palpable tes<cle, to whom, during laparoscopy, it is corroborated 
that the deferens and tes<cular vessels enter the internal inguinal oriﬁce, and that 
this is closed, corrobora<ng by inguinal surgery the presence of a viable tes<cle, 
and that it can be descended via inguinal open approach. 
 
• The pa<ent who abandons the outpa<ent follow-up. 
 
• Pa<ents with evanescente testes. 
 
• Pa<ents with intra-abdominal dysgenic or atrophic tes<s. 
 
• Subjects transferred to another ins<tu<on. 
 
• Subjects whose parents decide to leave the INP voluntarily. 
 
 
Loca3on: It will be performed in the department of General Surgery of the Na<onal 
Ins<tute of Pediatrics. The pa<ents will be recruited by the surgery outpa<ent clinic, with a 
diagnosis of cryptorchidism with non-palpable tes<cle, who will be invited to par<cipate in 
the study a_er a medical evalua<on by an assigned, which clinically corroborates the 

 
 
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picture of a "non-palpable tes<cle". The parents of the par<cipants will be explained the 
diagnosis of the pa<ent. The diagnos<c and therapeu<c possibili<es, as well as the follow-
up they will have to follow, and their study protocol will be completed, which includes 
complete blood biometry, coagula<on <mes, preopera<ve inguinoscrotal USG performed 
in the INP, with measurement of tes<cular volume, as well as the characteris<cs of the 
internal inguinal oriﬁce, the inguinal canal bilaterally (healthy or diseased). 
 
Classiﬁca3on of research 
 
Quasi-experimental study 
 
Sampling:  Non-probabilis<c sampling 
 
Process 
 
In pa<ents with a non-palpable tes<cle, it will be scheduled for explora<on under seda<on 
in the opera<ng room (Figure 6) 
 
 
Anesthe3c technique 
 
A_er a preopera<ve anesthe<c evalua<on, the pa<ent will go to the opera<ng room to be 
explored under seda<on with inhala<on anesthesia with 1-5% sevoﬂorane. In those cases 
in which the diagnosis of non-palpable tes<cle is corroborated, a diagnos<c laparoscopy will 
be performed under balanced general anesthesia (propofol 2mgkdo + opioid 2mckgdo + 
rocuronium 0.6mgkgdo), caudal block will be performed with administra<on of local 
anesthe<c based on ropivacaine 2% at a rate of 2-3mg/kg of weight, and volume depending 
on the desired metamere to be achieved, will be calculated at a rate of 1.6ml to achieve the 
T4 metamere. Maintenance will be with anesthe<c gas, sevoﬂorane at a CAM (Minimum 
Alveolar Concentra<on) of 2%.  
 
Diagnos3c and/or therapeu3c laparoscopy 
 
Diagnos<c laparoscopy consists of placing a 5mm trocar via the umbilicus to introduce a 
laparoscopic lens and conﬁrm the presence of the intra-abdominal tes<cle.  
 
If the intra-abdominal loca<on is conﬁrmed, 2 more working trocars are placed on both 
ﬂanks. The following measurements are then documented (Figure 3): a) Measurement of 
the emergence of the gonadal vessels in the posterior part of the abdomen 
(retroperitoneum), passing through the paravesical tract through which the tes<cle will 
descend, un<l reaching the middle 1/3 of the scrotum, with a suture (prolene vascular 2 
zeros) which is introduced to the cavity, just above the pubis, in such a way that the cephalic 
end of this suture will touch the emergence of the gonadal vessels (retroperitoneum), and 

 
 
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the caudal end will touch the middle 1/3 of the scrotum (A-A') See ﬁgure 3. This 
measurement will be very useful since it will determine if the ﬁnal length of mobiliza<on of 
the aﬀected tes<cle will be op<mal for its primary descent or if it will require a second <me. 
This maneuver will be contrasted with the maneuver described by Shehata (Figure 5, image 
2), as an evalua<on of the length of the vascular pedicle. 
 
At this point, a plain abdominal radiograph is taken to determine the distance between the 
gonadal vessels' emergence and the scrotum's middle third, along with a radiopaque ruler 
to document the distance radiographically. 
 
A second measurement will be performed with a 2nd suture, which will be introduced 
percutaneously at the level of the contralateral inguinal oriﬁce. The cephalic end will touch 
the same site of the emergence of the aﬀected gonadal vessels, and the caudal end will be 
the contralateral inguinal oriﬁce (B-B'). An addi<onal measurement to this same 
measurement will be the addi<onal length provided by the maneuver of touching the roof 
of the abdominal wall in the middle third of this distance (C-C'), as described by Shehata 
(Figure 6, image 2). These measurements will help us to contrast them with previously 
published maneuvers, and to see if they corroborate with our ini<al measurement (middle 
1/3 of scrotum-emergence of gonadal vessels distance A-A'). 
 
 
Figure 6.  
 
 
Likewise, the distance of the intra-abdominal tes<cle with respect to the ipsilateral internal 
inguinal oriﬁce will be measured with the same technique (percutaneous), for sta<s<cal 
and documenta<on purposes, as well as the real dimensions of the tes<cle prior to its 
surgical mobiliza<on, with a laparoscopic ruler.  
 
Determina3on of VILO Vs Shehata: 
 
The determinant for assigning the VILO Vs Shehata technique will be the length of the 
vascular pedicle measured transopera<vely: During laparoscopy, a_er documen<ng the 
distances previously described, the Gubernaculum tes<s is cut to begin tes<cular 
mobiliza<on, preserving the deferens, with its vasculature, as well as the gonadal vessels 
(gonadal artery and vein). The dissec<on/release of the lateral peritoneum covering the 
deferens extends to the bladder and the release of the peritoneum covering the gonadal 
vessels extends to visualize the ipsilateral deferens and the edge of the cecum, or the 
ascending colon, as the case may be. A_er this release of the aﬀected tes<cle, it is insinuated 
in front of the oriﬁce of the contralateral internal inguinal ring, while with another forceps 
(simultaneously), the midpoint of this mesentery tes<cular (deferens and gonadal vessels) 
is approached trying to touch the roof of the abdominal wall in the midline. With this 
maneuver described by Shehata, it is intended to determine if the tes<cle can be descended 

 
 
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in a single surgical <me (VILO technique), or if it will be a candidate for a serial elonga<on 
process, described by Shehata, with reinterven<on at 12 weeks post-surgery (See ﬁgure 
5(69) and 6). Thus, it is not possible to randomize pa<ents to determine which technique to 
perform, since if the pa<ent's tes<cle is long enough, it would not make sense to perform 
Shehata's orchidopexy. 
 
 
VILO group: Pa<ents that the intra-abdominal tes<cle that reaches without any problem the 
contralateral internal inguinal oriﬁce, and that, by means of a second laparoscopic clamp, 
this elevates the vascular pedicle and the deferens and can touch the anterior abdominal 
wall without diﬃculty (Figure 3), a primary descent will be performed, by crea<ng a neotray, 
via the paravesical route, medial to the epigastric vessels, to directly descend the aﬀected 
tes<cle towards the ipsilateral scrotum by means of a scrotal incision in the middle third. 
 
Shehata group: Those tes<cles that, despite having performed a gentle and extensive 
mobiliza<on of the intra-abdominal tes<cle, will akempt to li_ the mesentery un<l it 
touches the abdominal wall. If the length is insuﬃcient with this maneuver, we will perform 
a serial laparoscopic orchidopexy with preserva<on of tes<cular vessels, as described by 
Shehata (Figure 5 and Image 1). This involves contralateral ﬁxa<on of the intra-abdominal 
tes<cle above the contralateral iliac crest by means of a vascular prolene point, preserving 
the tes<cular vessels and the vas deferens and its circula<on. The laparoscopic wounds are 
closed, and the pa<ent goes on to recovery.  
 
Image 1.  
 
Subsequently, it is programmed at 12 weeks, prior to abdominal Doppler USG, to document 
the tes<cular posi<on and characteris<cs prior to the 2nd surgical <me. During the second 
laparoscopy <me, once the tes<cle is located, it is released from the ﬁxa<on to the 
abdominal wall, and the ﬁnal elonga<on of the vascular pedicle is documented with the 
same maneuver described by Shehata (image 2). The tes<cle is descended through an 
ipsilateral paravesical neotrayectum, un<l it is exteriorized through an incision in the middle 
third of the scrotum, ﬁxing it with 2 prolene s<tches to the scrotal tarsal. 
 
Image 2.  
 
 
Inguinoscrotal surgical <me: The inguinoscrotal part in both techniques will be performed 
through a transverse incision in the middle third of the scrotum, for which, using a blunt 
laparoscopic dissector, the ipsilateral paravesical neo tract is created, suprapubic, 
exteriorizing the dissector through this same incision. The trajectory is extended un<l it 
allows tes<cular extrac<on/descent to the scrotum (image 3). The tes<cle will be measured 
in its longitudinal and transversal dimensions by means of a metallic ruler, in addi<on to 
photographically documen<ng the gonad, in search of malforma<ons of the deferens. 

 
 
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28 
Subsequently, each pole of the ipsilateral scrotal dartos will be punctured with simple 
vascular prolene s<tches. Dartos closure with vicryl surgete 4 zeros, and skin with 
absorbable suture. 
 
Image 3 
 
 
Subsequently, the pa<ent will go to recovery to be discharged to the ﬂoor for one night. The 
following day, outpa<ent management will be assessed.  
 
Both groups will be monitored by means of a clinical review by the outpa<ent clinic one 
week a_er surgery and also at 3 and 6 months a_er surgery with a Doppler USG to visualize 
the irriga<on and tes<cular volume and document the posi<on of the aﬀected tes<cle. 
 
Shehata's group should have a post-surgical follow-up between 7-10 days a_er the ﬁrst 
surgery and an appointment at 11 weeks for their preopera<ve evalua<on of the 2nd 
surgical <me. 
 
For the Shehata group, if it is documented that the tes<cle "fell out of contralateral ﬁxa<on" 
during the second laparoscopic interven<on, the gonad will be re-ﬁxed to complete its 
descent again 12 weeks later. This pa<ent will be included in the ﬁnal analysis.  
 
Figure 7.  
 
Postopera3ve management. 
 
A_er the surgical procedure, pa<ents will remain in recovery un<l showing anesthe<c 
recovery, with mobiliza<on of their extremi<es, normal vital signs, absence of pain, and 
tolerance to oral ﬂuids by mouth.  
 
 
Once the interven<ons are concluded, the pa<ents will be sent home with a prescrip<on 
with instruc<ons with oral analgesics with Paracetamol (10mkdo) every 6hrs for the ﬁrst day 
of surgery, followed by 3 days, with a schedule every 8hrs. Daily bath with soap and water, 
with wound cleansing. Wriken alarm data. 
 
Those pa<ents who do not present the minimum condi<ons for discharge will remain 
hospitalized for at least 24 hours for a new evalua<on and possible discharge.  
 
 
 
 
 
 

 
 
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29 
Follow-up: 
 
1st consulta3on 7-10 days post-surgery: The healing of the laparoscopic and scrotal wounds 
will be assessed in those who have undergone scrotal orchidopexy. 
 
2nd consulta3on 12-13 weeks post-surgery: Preliminary clinical results of post-surgical 
loca<on will be evaluated, in addi<on to ruling out post-surgical complica<ons, such as 
inguinal hernia, umbilical hernia, and tes<cular atrophy. An inguino-scrotal USG will also be 
performed, with determina<on of gonadal size and remeasurement of both inguinal 
oriﬁces.  
 
3rd consulta3on, 6 months aber surgery: Clinical review, evalua<on by USG Doppler with 
measurement of tes<cular volume, tes<cular dimensions, and presence of any wall defect.  
 
4th consulta3on, 12 months aber surgery: Clinical review, evalua<on by USG Doppler with 
measurement of tes<cular volume, tes<cular dimensions, and presence of any wall defect.  
 
Annual follow-up: color Doppler USG, with tes<cular measurements and clinical review. 
 
Eﬃcacy is considered if the corrected tes<cle remains in the lower or middle por<on of the 
scrotum, and safety if it retains more than 75% of the ini<al volume calculated by USG, or if 
it retains its normal vascularity, or that, from direct measurements, at the <me of descent 
into the scrotum. The tes<cles that lodge in high scrotal posi<on, or higher, as well as those 
with a decrease in tes<cular volume of less than 75%, or with altera<ons in the color 
Doppler, will be considered failed correc<ons. 
 
Ultrasonography measurements 
 
Tes<cular Doppler USG will be performed preopera<vely at 12-13 weeks post-surgery, 
prior to the 2nd surgical <me, and 6 months a_er surgery. Paying aken<on to the 
determina<on of tes<cular size and volume, as well as tes<cular irriga<on, in addi<on to 
the inguinal explora<on to determine the characteris<cs of both internal inguinal oriﬁces 
and the inguinal canal. This study will be performed by outpa<ent, through the radiology 
department.  
 
 

 
 
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10. Flowchart 
 
Figure 8.  
 
 

 
 
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11. Sample size. 
 
Exact - Proportion: Sign test (binomial test) 
Analysis: 
A priori: For the estimation of a proportion of patients with non-palpable testicles, where a 
moderate effect of 0.3 is considered.  
Input: 
Tail(s) 
= Two 
 
Effect size g 
= 0.3 
 
α err prob 
= 0.05 
 
Power (1-β err prob) 
= 0.80 
Output: 
Lower critical N 
= 5.0000000 
 
Upper critical N 
= 15.0000000 
 
Total sample size 
= 20 
 
Actual power 
= 0.8042080 
 
Actual α 
= 0.0413895 
 
A cutoﬀ will also be performed when 16 pa<ents are reached, and a post hoc analysis will 
be performed.  
 
Exact - Proportion: Difference from constant (binomial test, one sample case) 
Options: 
α balancing: α/2 on each side 
Analysis: 
Post hoc: Compute achieved power  
Input: 
Tail(s) 
= Two 
 
Effect size g 
= 0.3 
 
α err prob 
= 0.05 
 
Total sample size 
= 16 
 
Constant proportion 
= 0.5 
Output: 
Lower critical N 
= 3.0000000 
 
Upper critical N 
= 13.0000000 
 
Power (1-β err prob) 
= 0.5981346 
 
Actual α 
= 0.0212708 
 
With a Beta of 60%.  
 
 
 
 
 
 

 
 
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12. Deﬁni6on of Variables. 
 
Outcome variables 
 
Objec3ves Variable 
Deﬁni3on 
Type of 
variable 
Measuring 
scale 
Number of 
measurements 
Security 
Tes<cular 
Atrophy 
Loss of 
tes<cular 
volume >50% 
of the ini<al 
tes<cular 
volume or a 
postopera<ve 
tes<cular 
volume <25% 
compared to 
the volume of 
the 
contralateral 
tes<cle.(86) 
Con<nuous 
numerical 
Cubic 
millimeters 
3 
Eﬃciency 
Anatomical 
success 
Placement of 
the diseased 
tes<cle in the 
middle or 
lower third of 
the scrotum. 
Dichotomous Present 
Absent 
1 
 
 
 
 

 
 
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13. Sta6s6cal Analysis. 
 
STATISTICAL ANALYSIS 
Descriptive statistics will be performed; continuous variables will be presented as 
arithmetic means and standard deviation for those with normal distribution or as 
medians or inter-quartile range for those without. The Shapiro-Wilk test will be used 
to evaluate the distribution of the data. To determine if there are statistical 
differences, the Xi2 test will be used for qualitative variables, and the Mann Whitney 
U test or Student's t-test for quantitative variables, depending on their distribution. In 
order to determine the differences between the baseline and final groups, Wilcoxon 
or paired t-tests will be used according to the distribution of the data. 
A per-protocol analysis will be performed, considering only patients who have 
completed the study, and an intention-to-treat analysis, in which all patients will be 
included. For this analysis, those patients who discontinue follow-up or who do not 
have all the follow-up variables will be considered, and the baseline measurement 
will be taken into account as the final measurement.  
According to the hypothesis, testicular atrophy in less than 5% was considered safe. 
The presence or absence of this will make it possible to obtain relative risk, relative 
risk reduction, absolute risk reduction, and finally, the number needed to be 
tartarized. The same can be obtained in the presence or absence of efficacy, 
measured by anatomical success. 
A p < 0.05 will be taken as statistically significant.  
Data will be analyzed using Stata 16.1 (College Station, Texas 77845 USA). 
 
 

 
 
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Ethical considera6ons. 
 
This is a health research project involving human subjects. This protocol involves 
therapeutic efficacy and does not intend to modify any therapeutic indication. It is a quasi-
experimental study in which a modification to a routine surgical procedure will be performed 
on subjects between 6 months and 7 years of age. 
The activities to be carried out during the development of this research project are in 
accordance with the provisions of Title Two, Chapter III of the Regulations of the General 
Health Law on Health Research. 
According to the risk classification, this protocol is considered greater than minimal 
risk for the patient. This is because, for research purposes, a procedure different from the 
conventional one will be performed in the surgical treatment of patients with intra-abdominal 
testicle in whom the testicular pedicle is not sufficient (it is not feasible to perform a primary 
descent). This procedure avoids the section of the testicular pedicle, as the conventional 
technique does. It is intended to reduce the frequency of testicular atrophy associated with 
conventional treatment.  
The development of the project will adhere to the latest version of the World Medical 
Association Declaration of Helsinki (1964), updated in 2008 and to the ethical guidelines 
proposed in "International Ethical Guidelines for Health-Related Research Involving Human 
Subjects, Fourth Edition. Geneva: Council for International Organizations of Medical 
Sciences (CIOMS) 2016". Likewise, to the criteria for the execution of research projects for 
health-related research in humans established by the Ministry of Health in the Official Journal 
of the Federation, Norma Oficial Mexicana NOM-012-SSA3-2012. 
The protocol will be submitted to the Instituto Nacional de Pediatría health research 
committees. It will begin once it has been approved. 
Patients will be included following the informed consent process, which will be 
requested from parents or guardians and documented in the Informed Consent form. Children 
older than 8 years of age will not be included, so an informed consent process signed by the 
minor will not be included.  
No blood samples will be obtained during the protocol. During visits 1, 2, and 3, a 
testicular ultrasound and a photograph of the scrotal area documenting the changes in the 
position of the testicle in the scrotum will be performed. In all cases, no photographs will be 
taken to identify the subject 
Once approved by the institutional committees of both hospitals, the research protocol 
will be registered in the Clinical Trials electronic database ( https://register.clinicaltrials.gov) 
in the experimental studies section. 
The monitoring, implementation, performance, recording, analysis, and notification 
of possible eventualities will be in compliance with the Good Clinical Practices established 
by the International Conference on Harmonization. 
The use and disposal of sensitive personal data of research subjects will be in 
accordance with the provisions of the Federal Law for the Protection of Personal Data in 
Possession of Individuals, in its articles 9, 11, 12, 13, 14, 15, 16, 19, 20 and 21. For this 
purpose, a Privacy Notice was prepared and will be documented for each research subject. 

 
 
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Public accountability for research will be conducted in accordance with Guideline 24: 
Public Accountability for Health-Related Research; proposed by the Council for International 
Organizations of Medical Sciences (CIOMS) 2016, to committees on research for health.  
When submitting this protocol to the health research committees, the authors declare 
that they have no conflict of interest in the development, conduct, analysis of results, and 
dissemination of information. Should any conflict of interest arise during the protocol's 
development, it will be reported to the Research Ethics Committee and during the 
dissemination of the information.  
The informed consent form was filled out according to the specifications provided by 
the National Institute of Pediatrics Research Ethics Committee. 
 
 
 

 
 
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15.- Biosafety 
 
This research presents a biological risk level of 1, according to the WHO(87), which 
corresponds to "likle or no individual and popula<on risk."  
 
For the purposes of this clinical trial, the acquisi<on of informa<on or measurement of 
variables will not include the use of biological material, nucleic acids, CRETI reagents, or 
radioac<ve sources in evalua<ng the safety or eﬃcacy of the interven<ons we perform. 
 
The infec<ous biological waste generated as part of the clinical care of these subjects is 
handled in accordance with the s<pula<ons of the clinical and laboratory areas set forth in 
the regulatory framework of the "FMS Facili<es Management and Safety Plan" for the 
Na<onal Pediatrics Ins<tute, which establishes the requirements for the separa<on, 
packaging, storage, collec<on, transporta<on, treatment and ﬁnal disposal of infec<ous 
biological waste generated in these areas. 
 
 
 
 
 
 
 
 

 
 
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16.- Research resources. 
 
Resources for this project will be obtained federally as follows: 
 
 
A) Human resources:  
a. Outpa<ent: One surgical resident and one surgical akending physician, two 
nurses are required. 
b. Surgery: An anesthesiologist and an anesthesiology resident are required, 
as well as a pediatric surgeon and a resident in pediatric surgery, four 
nurses, two in the opera<ng room, one in the recep<on area, and one in 
the recovery area.  
c. Radiology: One seconded Radiologist, one X-ray technician, and one X-ray 
resident.  
 
B) Material Resources:  
a. Outpa<ent: We have an oﬃce with an examina<on table, desk, outpa<ent 
computer, and electronic medical record so_ware. We also have a 
somatometry area for determining weight and height, with basic 
equipment (a scale for children under 10kg and a scale for preschoolers, 
schoolchildren, and adolescents). 
b. Ultrasound: We have an ultrasound diagnos<c area with 2 ultrasound 
machines, a scanning table, and so_ware for image review (PACS). 
c. Opera<ng Room: We have a laparoscopy tower and 5mm instruments, as 
well as the necessary supplies. 
d. Hospitaliza<on: The INP has surgical residents in all four grades of training 
(R1, R2, R3, R4, and chief resident), in addi<on to 24-hour nursing staﬀ and 
orderlies. 
 
 
C) Infrastructure: There is an opera<ng room with all the necessary and indispensable 
elements for research.  
 
 
 

 
 
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17. Budget.  
 
The costs were calculated based on the "Tabulador de cuotas de recuperación 2023", with 
SHCP authoriza<on leker No. 349-B-273. Of which, we men<on the following 
 
 
Concept 
Cost Level K 
Consulta<on with folio 
119 pesos 
Opening of ﬁle 
38 pesos 
Pre-consulta<on 
54 pesos 
Subspecialist Consulta<on 
1150 pesos 
Abdominal Doppler ultrasound of 2 regions 
2210 pesos 
Anesthe<c seda<on 
2868 pesos 
General Anesthesia 
6253 pesos 
Orchidopexy Surgery 
22,781 pesos 
 
Thus, each pa<ent will have a diﬀerent cost, depending on the management technique 
used. Below, we present the cost, including the pa<ents that will be invited to par<cipate, 
and that once they are in the opera<ng room, under anesthesia, it will be possible for 
several of these pa<ents to have their tes<cles touched in the inguinal canal. The cost of 
their treatment is included.  
 
 
Concept 
Unit Cost Level K 
Weights  
VILO 
Shehata 
Eliminated 
Consulta<on with folio 
119 pesos 
119 
119 
119 
Opening of ﬁle 
38 pesos 
38 
38 
38 
Pre-consulta<on 
54 pesos 
54 
54 
54 
Subspecialist Consulta<on 
1,150 pesos 
4,600 
8,050 
4,600 
Abdominal Doppler 
ultrasound of 2 regions 
2,210 pesos 
6,630 
6,630 
4420 
Anesthe<c seda<on 
2,868 
0 
0 
0 
General Anesthesia 
6,253 pesos 
6,253 
12,506 
6253 
Orchidopexy Surgery 
22,781 pesos 
22,781 
45,562 
22,781 
Total 
 
40475 
72959 
38,265 
 
 
 
 
 
 

 
 
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We consider that 30 pa<ents will need to be recruited, es<ma<ng that approximately 20% 
during seda<on may be palpated in the inguinal region in addi<on to possible leakage. 
However, these pa<ents will con<nue with general anesthesia at that <me for the 
correc<on of their cryptorchidism openly via the inguinal route. However, for the analysis, 
these pa<ents will be excluded.  
 
Of the remaining 20 pa<ents, we consider that approximately half of the pa<ents will 
require treatment according to Shehata, and the rest will be amenable to treatment with 
the VILO technique, so the costs are as follows.  
 
Technique 
Individual cost 
Including 
Total cost 
VILO 
40,475 
10 
404,750 
Shehata 
72,959 
10 
729,590 
Removed (Inguinal) 
38,265 
10 
382,650 
Total cost: 
 
 
1,516,990 
 
 
This gives a total cost of 1,516,990 pesos.  
 
 
 
 

 
 
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