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One Stage vs. Two Stage Gubernaculum Sparing Laparoscopic Orchidopexy (GSLO)

NCT02936024 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-10-19

No results posted yet for this study

Summary

Undescended Testis (UDT) is the most common congenital anomaly of the genitalia in boys and it is commonly managed by surgical intervention. Patients with intra-abdominal or non palpable testis, specifically, are often managed using a laparoscopic assisted orchidopexy, a common surgical technique to bring undescended testes down into the scrotum. Evidence in the medical literature to support the superiority of either one stage or two stage gubernaculum sparing laparoscopic orchidopexy (GSLO) is lacking. Due to this reason, this study focuses on the effects of one stage versus two stage GSLO on a patient important outcome: testicular atrophy.

Conditions

  • Cryptorchidism

Interventions

PROCEDURE

Two-Stage GSLO Technique

The patient will initially receive the first stage of the two-stage technique which involves the ligation of testicular vessels laparoscopically, or transection of these vessels using cautery. After the first stage is complete, the patient will be seen approximately 3-6 months later for the second stage. The second stage of the procedure involves free mobilization of the testis and placement/fixation of the testicle in the scrotum.

PROCEDURE

One-Stage GSLO Technique

The patient will receive only one surgical procedure during which ligation of testicular vessels is performed, as well as mobilization of the testis and placement/fixation of the testicle in the scrotum.

Sponsors & Collaborators

Principal Investigators

  • Luis H Braga, M.D. · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-11
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Canada

Study Locations

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Entities

Companies

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 NCT02936024 on ClinicalTrials.gov