NCT02235623 Orchidopexy Randomized Clinical Assessment
| NCT ID | NCT02235623 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | Unilateral Cryptorchidism |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2014-08 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2014-08 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a randomized trial designed to evaluate testicular outcomes after a single stage versus a two-stage surgical procedure to fix an undescended, one-sided testicle located in the abdomen. Also to determine and compare the costs, surgical complications and the health related quality of life for the two procedures. Testicular outcomes will be measured using a scrotal ultrasound 6-12 months after the procedure (after the second stage procedure for those randomized to a 2 stage surgery).
Eligibility 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.
Contact & Investigator
Caleb P Nelson, MD, MPH
PRINCIPAL INVESTIGATOR
Boston Children's Hospital
Frequently Asked Questions
Who can join the NCT02235623 clinical trial?
This trial is open to male participants only, aged 4 Months or older, up to 36 Months, studying Unilateral Cryptorchidism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02235623 currently recruiting?
Yes, NCT02235623 is actively recruiting participants. Contact the research team at Badar.Omar@childrens.harvard.edu for enrollment information.
Where is the NCT02235623 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT02235623 clinical trial?
NCT02235623 is sponsored by Boston Children's Hospital. The principal investigator is Caleb P Nelson, MD, MPH at Boston Children's Hospital. The trial plans to enroll 66 participants.