Comparing two surgical methods for fixing an undescended testicle in boys
Official title: Randomized Trial of One Stage vs Two Stage Orchidopexy for Abdominal Undescended Testis
Run by Boston Children's Hospital · NCT02235623 · Data updated 2026-11-12
This study is testing which of two surgical methods works better for fixing an undescended testicle in boys and how it affects their health and quality of life afterward.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Months to 36 Months |
| Sex | Men only |
| Enrollment | 66 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | August 2014 |
| Main results expected | December 31, 2030 |
| Study ends | December 31, 2030 |
| Registry record updated | April 15, 2026 |
| Trial ID | NCT02235623 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are boys aged 4 to 36 months undergoing diagnostic laparoscopy for unilateral non-palpable testis.
✕Probably not a fit
Patients older than 36 months, younger than 4 months, or those with bilateral cryptorchidism will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial evaluates the outcomes of a single-stage versus a two-stage surgical procedure for boys with unilateral cryptorchidism, specifically focusing on testicular health after surgery. Participants will undergo diagnostic laparoscopy to assess the condition of the undescended testis, followed by the appropriate orchidopexy procedure. The study will also analyze costs, surgical complications, and the quality of life related to health for both surgical approaches, with outcomes measured via scrotal ultrasound 6-12 months post-operation.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques and better health outcomes for boys with undescended testicles.
How similar studies have gone: Other studies have explored similar surgical techniques, but the specific comparison of single-stage versus two-stage Fowler-Stephens orchidopexy is less common.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Boys age 4 months to 36 months * Undergoing diagnostic laparoscopy for unilateral non-palpable testis, who are found at laparoscopy to have an abdominal undescended testis, in whom a Fowler-Stephens Orchiopexy would be appropriate. Exclusion Criteria: * Age \> 36 months * Age \< 4 months * Bilateral cryptorchidism * Solitary testis * Findings at laparoscopy for which Fowler-Stephens Orchiopexy would not be indicated * Intra-operative mobility of the intra-abdominal testis such that, with no (or minimal) mobilization, the testis is able to reach the contralateral internal ring, without dividing the spermatic vessels. * Assessment of whether a single stage primary orchidopexy will be performed, is entirely at the discretion of the attending surgeon.
Where it's running
-
Boston Children's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Caleb P Nelson, MD, MPH — Boston Children's Hospital
- Study coordinator: Badar Omar, BA
- Email: Badar.Omar@childrens.harvard.edu
- Phone: 617-919-6352
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.