One Stage vs. Two Stage Gubernaculum Sparing Laparoscopic Orchidopexy (GSLO) (NCT02936024) | Clinical Trial Compass
UnknownNot Applicable
One Stage vs. Two Stage Gubernaculum Sparing Laparoscopic Orchidopexy (GSLO)
Canada80 participantsStarted 2017-04-11
Plain-language 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.
Who can participate
Age range
1 Year – 5 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of Postoperative Testicular Atrophy at 3 Months
Timeframe: 3 months postoperatively
2
Rate of Postoperative Testicular Atrophy at 12 Months
Timeframe: 12 months postoperatively
3
Recruitment Rate
Timeframe: Through study completion, an average of 2 years
4
Frequency of protocol violations
Timeframe: Through study completion, an average of 2 years
5
Frequency of adverse events
Timeframe: Through study completion, an average of 2 years