Comparing two surgical methods for fixing an undescended testicle in boys
Randomized Trial of One Stage vs Two Stage Orchidopexy for Abdominal Undescended Testis
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 4 Months to 36 Months |
| Sex | Male |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT02235623 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are boys aged 4 to 36 months undergoing diagnostic laparoscopy for unilateral non-palpable testis.
Not a fit: Patients older than 36 months, younger than 4 months, or those with bilateral cryptorchidism will not benefit from this study.
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 performed: Other studies have explored similar surgical techniques, but the specific comparison of single-stage versus two-stage Fowler-Stephens orchidopexy is less common.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
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.