Fowler-Stephens Orchidopexy for Undescended Testicles
(ORCA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Do I need to stop my current medications for the trial?
The trial information does not specify whether participants need to stop taking their current medications.
How does Fowler-Stephens orchidopexy differ from other treatments for undescended testicles?
Fowler-Stephens orchidopexy is unique because it involves dividing the short testicular vessels to allow the testis to be placed in the scrotum, relying on alternative blood supply routes. It can be performed in one or two stages, which is different from other treatments that may not address the issue of short vessels in the same way.12345
What data supports the effectiveness of the treatment Fowler-Stephens orchidopexy for undescended testicles?
Research shows that both single-stage and two-stage Fowler-Stephens orchidopexy are effective for treating undescended testicles, especially when they are located high in the abdomen. Studies have compared these methods and found them to be successful in positioning the testicles correctly, with factors like testicular atrophy (shrinkage) and malpositioning being important considerations.34567
Who Is on the Research Team?
Caleb P Nelson, MD, MPH
Principal Investigator
Boston Children's Hospital
Are You a Good Fit for This Trial?
This trial is for boys aged 4 to 36 months with one undescended testicle located in the abdomen, suitable for Fowler-Stephens Orchiopexy (FSO). It's not for those with a solitary testis, bilateral cryptorchidism, or if the testis can reach the opposite internal ring without cutting spermatic vessels.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either a single-stage or two-stage Fowler-Stephens orchidopexy to fix an undescended testicle
Follow-up
Participants are monitored for testicular outcomes using scrotal ultrasound
What Are the Treatments Tested in This Trial?
Interventions
- Single-stage Fowler-Stephens orchidopexy (FSO)
- Two-stage Fowler-Stephens orchidopexy (FSO)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor