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Procedure

One-Stage vs Two-Stage Orchidopexy for Undescended Testicles (GSLO Trial)

N/A

Recruiting

Led By Luis H Braga, M.D.

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients diagnosed with intraabdominal UDT

Boys 1-5 years of age at presentation to Pediatric Urology Clinics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

GSLO Trial Summary

This trial found that one stage GSLO does not lead to an increased risk of testicular atrophy when compared to the two stage GSLO surgery.

Who is the study for?

This trial is for boys aged 1-5 with undescended testicles located inside the abdomen, who haven't had previous laparoscopic surgery for this condition. The procedure will be done by specialized Pediatric Urologists.Check my eligibility

What is being tested?

The study compares two surgical methods to correct undescended testicles: a one-stage and a two-stage technique using laparoscopy. It aims to determine which method better prevents testicular atrophy, or shrinkage of the testes.See study design

What are the potential side effects?

Potential side effects may include discomfort, swelling, infection risk at the incision site, bleeding, or damage to surrounding tissues during surgery. Long-term risks could involve fertility issues due to testicular atrophy.

GSLO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with undescended testicles within my abdomen.

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I am a boy between 1-5 years old seeing a pediatric urologist.

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I need a specialized surgery for my condition, performed by a trained Pediatric Urologist.

GSLO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency of adverse events

Frequency of protocol violations

Rate of Postoperative Testicular Atrophy at 12 Months

+2 more

GSLO Trial Design

2Treatment groups

Experimental Treatment

Group I: Intervention Group: Two-Stage GSLO TechniqueExperimental Treatment1 Intervention

Gubernaculum-sparing laparoscopic orchidopexy will be done in two stages

Group II: Control Group: One-Stage GSLO TechniqueExperimental Treatment1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

McMaster Surgical AssociatesOTHER

16 Previous Clinical Trials

46,439 Total Patients Enrolled

McMaster UniversityLead Sponsor

881 Previous Clinical Trials

2,597,806 Total Patients Enrolled

Luis H Braga, M.D.Principal InvestigatorMcMaster University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is this investigation being participatory?

"Affirmative, clinicaltrials.gov lists this trial as actively searching for participants with an original post date of April 11th 2017 and a most recent update on April 4th 2022. The study is aiming to find 80 volunteers at one site in total."

Answered by AI

Are there still opportunities to participate in this clinical research?

"Per records on clinicaltrials.gov, recruitment for this study is still underway. It was initially posted in April 2017 and last altered a few days ago, at the start of April 2022."

Answered by AI

Is this clinical trial open to persons aged 35 and above?

"This research study necessitates that those recruited are between 1 year and 5 years of age. There are an additional five investigations targeting patients under the legal age of consent, as well as one for people above 65."

Answered by AI

What qualifications must a person possess to be accepted into this medical experiment?

"Candidates who have cryptorchidism and are within the age range of 1 to 5 years can apply for recruitment into this clinical trial, which is set to accept up to 80 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "One Stage vs. Two Stage Gubernaculum Sparing Laparoscopic Orchidopexy (GSLO)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02936024.