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

NCT05845515 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-05-06

No results posted yet for this study

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

Interventions

PROCEDURE

laparoscopic orchiopexy

laparoscopic or open orchiopexy and comparison between the two groups

Sponsors & Collaborators

  • South Valley University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2023-05-15
Completion
2023-06-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05845515 on ClinicalTrials.gov