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

NCT02936024 | Unknown DMC

• 1 other identifier: GSLO
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Rate of Postoperative Testicular Atrophy at 3 Months

  How many children have been diagnosed with testicular atrophy 3 months after the surgery has been performed.

  3 months postoperatively

• Rate of Postoperative Testicular Atrophy at 12 Months

  How many children have been diagnosed with testicular atrophy 12 months after the surgery has been performed.

  12 months postoperatively

• Recruitment Rate

  Will be calculated as the percentage of eligible participants enrolled

  Through study completion, an average of 2 years

• Frequency of protocol violations

  Will be calculated as the number of protocol violations that occurred during the pilot phase of this trial.

  Through study completion, an average of 2 years

• Frequency of adverse events

  Will be calculated as the number of documented adverse events during the pilot phase of this trial.

  Through study completion, an average of 2 years

Study Arms (2)

Intervention Group: Two-Stage GSLO Technique

EXPERIMENTAL

Gubernaculum-sparing laparoscopic orchidopexy will be done in two stages

Procedure: Two-Stage GSLO Technique

Control Group: One-Stage GSLO Technique

OTHER

Gubernaculum-sparing laparoscopic orchidopexy will be done in a single stage

Procedure: One-Stage GSLO Technique

Interventions

Two-Stage GSLO Technique PROCEDURE

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.

Intervention Group: Two-Stage GSLO Technique

One-Stage GSLO Technique PROCEDURE

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.

Control Group: One-Stage GSLO Technique

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• boys 1-5 years of age at presentation to Pediatric Urology Clinics
• patients diagnosed with intraabdominal UDT
• patients who require one- or two-stage repair performed by fellowship-trained Pediatric Urologists

You may not qualify if:

• patients who have undergone previous laparoscopic orchidopexy
• patients with palpable testes
• patients requiring orchiectomy

Sponsors & Collaborators

• McMaster University: lead
• McMaster Surgical Associates: collaborator

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

MeSH Terms

Conditions

Cryptorchidism

Condition Hierarchy (Ancestors)

Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urogenital Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Luis H Braga, M.D.

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis H Braga, M.D.

CONTACT

905-521-2100; braga@mcmaster.ca

Melissa McGrath

CONTACT

905-521-2100; mcgram2@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 18, 2016
• Study Start: April 11, 2017
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)