- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02235623
Orchidopexy Randomized Clinical Assessment (ORCA)
February 8, 2024 updated by: Caleb Nelson, Boston Children's Hospital
Randomized Trial of One Stage vs Two Stage Orchidopexy for Abdominal Undescended Testis
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).
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Badar Omar, BA
- Phone Number: 617-919-6352
- Email: Badar.Omar@childrens.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Boston Children's Hospital
-
Contact:
- Rachel Saunders, BA
- Phone Number: 617-355-4720
- Email: Rachel.Saunders@childrens.harvard.edu
-
Principal Investigator:
- Caleb P Nelson, MD, MPH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 1 year (Child)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO)
Stage 1 single surgery to clip the vessels to the testis, divide the spermatic vessels and bring the testis into the scrotum.
|
|
Other: Stage 2- Two-stage Fowler-Stephens orchidopexy (FSO)
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the volume of the operated testis via ultrasound measurements.
Time Frame: 6-12 months after final FSO surgery
|
To evaluate the volume of the operated testis at 6-12 months after single-stage Fowler-Stephens orchidopexy (FSO) (6-12 months after two- stage FSO), as determined by ultrasound measurements.
This will be compared to the intra-operative testicular measurements done during the laparoscopy.
|
6-12 months after final FSO surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Caleb P Nelson, MD, MPH, Boston Children's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
September 2, 2014
First Submitted That Met QC Criteria
September 8, 2014
First Posted (Estimated)
September 10, 2014
Study Record Updates
Last Update Posted (Actual)
February 9, 2024
Last Update Submitted That Met QC Criteria
February 8, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P00008033
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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