Recruiting

GSLO vs. Two Stage

Sponsor:

McMaster University

Code:

NCT02936024

Conditions

Cryptorchidism

Eligibility Criteria

Sex: Male

Age: 1 - 5

Healthy Volunteers: Not accepted

Interventions

Two-Stage GSLO Technique

One-Stage GSLO Technique

Study Details

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

Study ID

NCT02936024

Start date

Apr 11, 2017

Status verified date

Oct, 2023

Completion date

Sep, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 1 - 5

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Group: Two-Stage GSLO Technique

Gubernaculum-sparing laparoscopic orchidopexy will be done in two stages

other: Control Group: One-Stage GSLO Technique

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

Interventions

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.

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.

Primary outcome measure

  • Rate of Postoperative Testicular Atrophy at 3 Months [ Time Frame: 3 months postoperatively ]
  • Rate of Postoperative Testicular Atrophy at 12 Months [ Time Frame: 12 months postoperatively ]
  • Recruitment Rate [ Time Frame: Through study completion, an average of 2 years ]
  • Frequency of protocol violations [ Time Frame: Through study completion, an average of 2 years ]
  • Frequency of adverse events [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts and Locations

Central contacts

Luis H Braga, M.D.

905-521-2100braga@mcmaster.ca

Melissa McGrath

905-521-2100mcgram2@mcmaster.ca

Locations

McMaster Children's Hospital

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

Luis Braga, MD

905-521-2100braga@mcmaster.ca

More Information

Sponsor

McMaster University

Last update posted

Oct 19, 2023

Last verified

Oct, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2023-10-19.