What side effects are associated with this type of intervention?

The most common treatment for undescended testicles is orchidopexy, which can be performed in one or two stages while sparing the gubernaculum. Known side effects of these procedures include testicular atrophy, infection, bleeding, and damage to surrounding structures. Additionally, there is a risk of the testicle reascending or not being fully secured in the scrotum. The two-stage approach may have a slightly lower risk of testicular atrophy compared to the one-stage procedure, but both methods aim to minimize complications while effectively repositioning the testicle.

What prior FDA approvals exist?

The treatment of undescended testicles (UDT) primarily involves surgical intervention, specifically orchidopexy, to reposition the testes into the scrotum. The FDA has not approved specific drugs for this condition, as the primary treatment is surgical. The trial comparing one-stage versus two-stage gubernaculum sparing laparoscopic orchidopexy (GSLO) focuses on surgical techniques rather than pharmacological treatments. Therefore, the mainstay of treatment remains surgical, with variations in technique being studied to optimize outcomes such as reducing testicular atrophy.

What other types of research exist?

Promising novel alternatives to One Stage vs Two Stage Gubernaculum Sparing Laparoscopic Orchidopexy for undescended testicles include: 1) Robotic-assisted laparoscopic orchidopexy, which offers enhanced precision and potentially better outcomes. 2) Hormonal therapy using human chorionic gonadotropin (hCG) or gonadotropin-releasing hormone (GnRH) analogs, which may be effective in selected cases. 3) Minimally invasive techniques such as micro-laparoscopic orchidopexy, which reduce recovery time and postoperative pain. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

← Back to Search

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

Must not have

Patients with palpable testes

Patients requiring orchiectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two surgical methods for moving undescended testicles in young boys. One method completes the surgery in a single procedure, while the other does it in multiple stages. The goal is to see which method better prevents testicle shrinkage.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with undescended testicles within my abdomen.

Select...

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

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I can feel my testicles when I touch them.

Select...

I need surgery to remove one or both of my testicles.

Select...

I have had surgery to correct an undescended testicle.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of adverse events

Frequency of protocol violations

Rate of Postoperative Testicular Atrophy at 12 Months

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for undescended testicles are surgical interventions, specifically orchidopexy. In the context of the one-stage and two-stage gubernaculum sparing laparoscopic orchidopexy (GSLO), the mechanism involves repositioning the undescended testicle into the scrotum while preserving the gubernaculum, a structure that aids in guiding the testicle during its natural descent. The one-stage procedure aims to complete this in a single surgery, whereas the two-stage approach involves an initial surgery to mobilize the testicle followed by a second surgery to complete the descent. Preserving the gubernaculum is crucial as it may reduce the risk of testicular atrophy and improve the chances of normal testicular function and fertility. This matters for patients because successful repositioning of the testicle can prevent complications such as infertility, testicular cancer, and psychological effects associated with undescended testicles.