Clinical trial NCT05845515: Laparoscopic Versus Open Orchiopexy in High Inguinal Undescended Testis, Prospective Randomized Clinical Trial
Official title: Laparoscopic Versus Open Orchiopexy in High Inguinal Undescended Testis, Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: We Conducted This Prospective Randomized Comparative Study to Compare Between Outcome of Laparoscopic and Open Orchiopexy of High Inguina
Keywords: laparoscopy , open , orchiopexy
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 200
Sex: MALE
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: We conducted this prospective randomized comparative study to compare between outcome of laparoscopic and open orchiopexy of high inguinal.

All children presented to us with high inguinal undescended testis diagnosed by history, clinical examination and inguino-scrotal ultrasound were included in this study.

We exclude children with previous history of inguinal surgery or unfit for anesthesia.

150 patients with inclusion criteria were randomized (using block randomization method by Stata, version 13.1, StataCorp, for Microsoft Windows R) into two groups: Group A: 75 cases who were operated with laparoscopic orchiopexy. Group B: 75 cases who were operated with open orchiopexy.

All of the patients were subjected to the following: Complete history taking, and Clinical examination: High inguinal undescended testis, is testicle felt at upper half of inguinal canal and can't manipulated to the scrotum Pre-operative routine Laboratory investigation and Pre-operative imaging: Inguino-scrotal \& colored Doppler ultrasound, were done for all patients. Patients were kept on fasting for 6 hours for solid food 2 hours for fluids before surgery. Informed written consent from all parents was obtained. All patients in our study underwent general anesthesia.

Detailed description: Cryptorchidism, or undescended testis, is a common congenital anomaly in male child, it accounts 1 to 4.6% of full-term infants at the age of 1 year.

This condition usually involves the testicle that fail to travel from the abdomen through the inguinal canal to the scrotum during fetal life., cryptorchidism usually classified as inguinal cryptorchidism and intra-abdominal cryptorchidism in clinical practice, about 80% of undescended testis can feel the testis in the inguinal canal (1).

Cryptorchidism more than 6 months needs orchiopexy. Although laparoscopy has used widely in management of intra-abdominal cryptorchidism, there were controversy for its use in the treatment of inguinal cryptorchidism (1).

Open surgical treatment of such high inguinal testes is the most popular approach among urologists. Due to the difficult surgical mobilization of some high inguinal testes, as well as significant complications, including testicular retraction/atrophy (3-18%), we hypothesized in this study that laparoscopic orchiopexy for such high inguinal testes will be an attractive alternative approach (2).

Patients and methods

We conducted this prospective randomized comparative study to compare between outcome of laparoscopic and open orchiopexy of high inguinal.

All children presented to us with high inguinal undescended testis diagnosed by history, clinical examination and inguino-scrotal ultrasound were included in this study.

We exclude children with previous history of inguinal surgery or unfit for anesthesia.

150 patients with inclusion criteria were randomized (using block randomization method by Stata, version 13.1, StataCorp, for Microsoft Windows R) into two groups: Group A: 75 cases who were operated with laparoscopic orchiopexy. Group B: 75 cases who were operated with open orchiopexy.

All of the patients were subjected to the following: Complete history taking, and Clinical examination: High inguinal undescended testis, is testicle felt at upper half of inguinal canal and can't manipulated to the scrotum Pre-operative routine Laboratory investigation and Pre-operative imaging: Inguino-scrotal \& colored Doppler ultrasound, were done for all patients. Patients were kept on fasting for 6 hours for solid food 2 hours for fluids before surgery. Informed written consent from all parents was obtained. All patients in our study underwent general anesthesia.

Eligibility criteria: Inclusion Criteria:

* all children presented with high inguinal undescended testis

Exclusion Criteria:

* previous inguinal surgery
* unfit patients

Primary outcomes:
measure: success of laparoscopy and open surgery in treatment of high inguinal testis
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley University
state: Qina
Study officials:
References: