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Fowler-Stephens Orchidopexy for Undescended Testicles (ORCA Trial)

N/A
Recruiting
Led By Caleb P Nelson, MD, MPH
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-12 months after final fso surgery
Awards & highlights

ORCA Trial Summary

This trial is comparing two different surgical methods for undescended testicles, measuring outcomes, complications, and quality of life.

Who is the study for?
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.Check my eligibility
What is being tested?
The study compares two surgical methods to correct an undescended testicle: Single-stage and Two-stage Fowler-Stephens orchidopexy. Outcomes are measured by scrotal ultrasound post-surgery and include cost analysis, complication rates, and quality of life impacts.See study design
What are the potential side effects?
Potential side effects from both surgeries may include pain at the surgery site, infection risk, bleeding complications or damage to surrounding structures during operation. Long-term outcomes like fertility could also be affected.

ORCA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-12 months after final fso surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-12 months after final fso surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the volume of the operated testis via ultrasound measurements.

ORCA Trial Design

2Treatment groups
Experimental Treatment
Group I: Stage 2- Two-stage Fowler-Stephens orchidopexy (FSO)Experimental Treatment1 Intervention
Stage 2 2 surgeries: 1st surgery-Clip vessels to testis. 2nd surgery done 6-12 months later, divide the spermatic vessels and bring the testis into the scrotum.
Group II: Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO)Experimental Treatment1 Intervention
Stage 1 single surgery to clip the vessels to the testis, divide the spermatic vessels and bring the testis into the scrotum.

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
769 Previous Clinical Trials
5,580,463 Total Patients Enrolled
Caleb P Nelson, MD, MPHPrincipal InvestigatorBoston Children's Hospital
1 Previous Clinical Trials
607 Total Patients Enrolled

Media Library

Single-stage Fowler-Stephens orchidopexy (FSO) Clinical Trial Eligibility Overview. Trial Name: NCT02235623 — N/A
Undescended Testicle Research Study Groups: Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO), Stage 2- Two-stage Fowler-Stephens orchidopexy (FSO)
Undescended Testicle Clinical Trial 2023: Single-stage Fowler-Stephens orchidopexy (FSO) Highlights & Side Effects. Trial Name: NCT02235623 — N/A
Single-stage Fowler-Stephens orchidopexy (FSO) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02235623 — N/A
~3 spots leftby Dec 2024
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