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

NCT05845515 | Unknown Phase 4

• 1 other identifier: SVU/MED/URO016/1.21.4.184
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

laparoscopy , open , orchiopexy

Outcome Measures

Primary Outcomes (1)

• success of laparoscopy and open surgery in treatment of high inguinal testis

  assess the outcome and success rate of laparoscopy and open surgery in treatment of high inguinal testis

  5 years

Study Arms (2)

laparoscopic orchiopexy

ACTIVE COMPARATOR

laparoscopic orchiopexy group

Procedure: laparoscopic orchiopexy

open orchiopexy

ACTIVE COMPARATOR

open orchiopexy group

Procedure: laparoscopic orchiopexy

Interventions

laparoscopic orchiopexy PROCEDURE

laparoscopic or open orchiopexy and comparison between the two groups

laparoscopic orchiopexy; open orchiopexy

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• all children presented with high inguinal undescended testis

You may not qualify if:

• previous inguinal surgery
• unfit patients

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley University

Qina, Qena Governorate, 831115, Egypt

Location

MeSH Terms

Interventions

Orchiopexy

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urology

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: January 1, 2018
• Primary Completion: May 15, 2023
• Study Completion: June 1, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)