Clinical trial NCT06558994: Transection Versus Ligation of Internal Spermatic Vessels in Laparoscopic Fowler-Stephens Orchidopexy
Official title: Transection Versus Ligation of Internal Spermatic Vessels in First Stage Laparoscopic Fowler-Stephens Orchidopexy for Intra-abdominal Testis. Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cryptorchidism
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 58
Sex: MALE
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a comparative study to see the outcome of yransection versus ligation of internal spermatic vessels in first stage laparoscopic Fowler-Stephens orchidopexy for intra-abdominal testis in assisting the descent of the testis to the base of scrotum during the second stage

Detailed description: Cryptorchidism is one of the most commin congenital deformities of male newborns, known as undescended testis (UDT). The incidence ranges according to gestational age, affecting 1.0-4.6% of full-term infants and 1.1-45% of preterm infants. (UDT) is a condition in which the testicles are not found at the base of the scrotum. Studies have shown that the undescended testicle has a potential of spontaneous descent during the first 3 months of life and is less likely to do so after 6 months of age. In almost 20% of cases the undescended testes are not palpable, increasing the difficulty of investigations and treatment, and 30% of these cases are also intra-abdominal. If UDT left untreated, it can cause histological alterations of the testicular cells and increasing of the risks of infertility.

As of treatment of UDT, laparoscopic surgery is ,for most surgeons, the preferred technique. Several techniques have been described for laparoscopic orchidopexy. After spermatic vascular transection, single-stage testicular descent fixing was carried out, as Fowler and Stephens (FSO) first described in 1959. Since 1996, a two-stage laparoscopic Fowler-Stephens technique involving preservation of the gubernacular vessels and performing an entirely laparoscopic second stage. The second stage is presently performed 6-9 months after the first.

Recently, laparoscopic FSO has been adopted to treat high-level IATs, for its minimally invasive wound and acceptable success rate.

Eligibility criteria: Inclusion Criteria:

All patients with Unilateral or Bilateral impalpable testis

Exclusion Criteria:

1. Previous Laparotomy surgery
2. Previous Ventriculo-peritoneal shunt
3. Previous laparoscopy for impalpable testis (outside study)
4. Previous Inguinal/Scrotal surgery
5. Disorder of sexual differentiation
6. Abnormal Karyotyping
7. Intra-operative Inguinal testis
8. Ipsilateral testis : Peeping/ Vas internal internal ring / Vanished / Streak / Ovotestis / Ovary.
9. Contralateral : Streak/ Ovotestis/ Ovary

Primary outcomes:
measure: testis-to-ring distance in mm at the second stage
timeFrame: At 6 months after the first stage (during the second stage)
measure: Testicular volume in mL
timeFrame: At 6 months after the first stage (during the second stage)
Secondary outcomes:
measure: Operative time in minutes
timeFrame: At 6 months after the first stage (during the second stage)
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Urology Hospital
Study officials:
affiliation: Assiut University
name: Mostafa M. Mostafa, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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