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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-12 months after final fso surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-12 months after final fso surgery
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
761 Previous Clinical Trials
5,579,664 Total Patients Enrolled
Caleb P Nelson, MD, MPHPrincipal InvestigatorBoston Children's Hospital
1 Previous Clinical Trials
607 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 3 years.Both of my testicles have not descended.My testis can be moved to the opposite side during surgery without cutting its blood supply.I have only one testicle.I am younger than 4 months old.My son is between 4 to 36 months old and needs surgery for an undescended testicle found in the abdomen.My surgeon will decide if I need a one-step surgery to correct undescended testicles.My condition does not require Fowler-Stephens Orchiopexy based on laparoscopy findings.
Research Study Groups:
This trial has the following groups:- Group 1: Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO)
- Group 2: Stage 2- Two-stage Fowler-Stephens orchidopexy (FSO)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can I sign up to help with this research?
"This study is only considering children that suffer from cryptorchidism and are between 4 months to 3 years old. There is space for 66 total participants in the trial."
Answered by AI
Is this study looking for more participants?
"This study is currently recruiting patients, with the latest update to the posting on clinicaltrials.gov being on October 10th, 2022. The study was originally posted on August 1st, 2014."
Answered by AI
Can people under 45 years old participate in this medical research?
"This trial is for patients who are between 4 months and 3 years old. Out of the 6 total trials, 5 are for children under 18 and 1 is for seniors over 65."
Answered by AI
How many people are going to be included in this experiment?
"Yes, the information on clinicaltrials.gov indicates that this clinical trial is presently looking for patients. The study was initially posted on 8/1/2014 and was most recently updated on 10/10/2022. The clinical trial is recruiting for 66 participants at 1 locations."
Answered by AI
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