Comparing one-stage and two-stage laparoscopic surgery for undescended testis in boys
One Stage vs. Two Stage Gubernaculum Sparing Laparoscopic Orchidopexy: A Randomized Controlled Trial
This study is testing whether one-stage or two-stage surgery for boys with undescended testicles leads to fewer problems after the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 1 Year to 5 Years |
| Sex | Male |
| Sponsor | McMaster University Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT02936024 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of a randomized controlled trial comparing one-stage versus two-stage gubernaculum sparing laparoscopic orchidopexy (GSLO) in boys aged 1-5 years with intra-abdominal undescended testis (UDT). The primary focus is on assessing postoperative testicular atrophy rates associated with each surgical approach. By determining the feasibility of this trial, the researchers aim to inform future multicenter studies that could establish best practices for managing UDT. The findings could lead to improved surgical guidelines and potentially reduce unnecessary exposure to general anesthesia in young children.
Who should consider this trial
Good fit: Ideal candidates are boys aged 1-5 years diagnosed with intra-abdominal undescended testis who require surgical intervention.
Not a fit: Patients who have previously undergone laparoscopic orchidopexy or have palpable testes will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced risk of testicular atrophy in boys with undescended testis.
How similar studies have performed: While this approach is novel in its specific comparison, similar studies have shown varying success in evaluating surgical techniques for undescended testis.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hamilton, Ontario
- McMaster Children's Hospital — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Luis H Braga, M.D. — McMaster University
- Study coordinator: Luis H Braga, M.D.
- Email: braga@mcmaster.ca
- Phone: 905-521-2100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.