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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
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 belowSelect...
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
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 moreAwards & 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
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.
Find a Location
Who is running the clinical trial?
McMaster Surgical AssociatesOTHER
16 Previous Clinical Trials
46,441 Total Patients Enrolled
McMaster UniversityLead Sponsor
918 Previous Clinical Trials
2,616,213 Total Patients Enrolled
Luis H Braga, M.D.Principal InvestigatorMcMaster University