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Laparoscopic Versus Open Orchiopexy in High Inguinal Undescended Testis, Prospective Randomized Clinical Trial

S

South Valley University

Status and phase

Active, not recruiting
Phase 4

Conditions

We Conducted This Prospective Randomized Comparative Study to Compare Between Outcome of Laparoscopic and Open Orchiopexy of High Inguina

Treatments

Procedure: laparoscopic orchiopexy

Study type

Interventional

Funder types

Other

Identifiers

NCT05845515
SVU/MED/URO016/1.21.4.184

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 patients

Sex

Male

Ages

6 months to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • all children presented with high inguinal undescended testis

Exclusion criteria

  • previous inguinal surgery
  • unfit patients

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

laparoscopic orchiopexy
Active Comparator group
Description:
laparoscopic orchiopexy group
Treatment:
Procedure: laparoscopic orchiopexy
open orchiopexy
Active Comparator group
Description:
open orchiopexy group
Treatment:
Procedure: laparoscopic orchiopexy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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