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Orchidopexy Randomized Clinical Assessment (ORCA)

Primary Purpose

Unilateral Cryptorchidism

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single-stage Fowler-Stephens orchidopexy (FSO)
Two-stage Fowler-Stephens orchidopexy (FSO)
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Cryptorchidism focused on measuring Laparoscopic Surgery, Orchiopexy

Eligibility Criteria

4 Months - 36 Months (Child)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO)

Stage 2- Two-stage Fowler-Stephens orchidopexy (FSO)

Arm Description

Stage 1 single surgery to clip the vessels to the testis, divide the spermatic vessels and bring the testis into the scrotum.

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.

Outcomes

Primary Outcome Measures

To evaluate the volume of the operated testis via ultrasound measurements.
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.

Secondary Outcome Measures

Full Information

First Posted
September 2, 2014
Last Updated
August 24, 2023
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02235623
Brief Title
Orchidopexy Randomized Clinical Assessment
Acronym
ORCA
Official Title
Randomized Trial of One Stage vs Two Stage Orchidopexy for Abdominal Undescended Testis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Cryptorchidism
Keywords
Laparoscopic Surgery, Orchiopexy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO)
Arm Type
Other
Arm Description
Stage 1 single surgery to clip the vessels to the testis, divide the spermatic vessels and bring the testis into the scrotum.
Arm Title
Stage 2- Two-stage Fowler-Stephens orchidopexy (FSO)
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Single-stage Fowler-Stephens orchidopexy (FSO)
Intervention Type
Procedure
Intervention Name(s)
Two-stage Fowler-Stephens orchidopexy (FSO)
Primary Outcome Measure Information:
Title
To evaluate the volume of the operated testis via ultrasound measurements.
Description
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.
Time Frame
6-12 months after final FSO surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Badar Omar, BA
Phone
617-919-6352
Email
Badar.Omar@childrens.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caleb P Nelson, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Saunders, BA
Phone
617-355-4720
Email
Rachel.Saunders@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Caleb P Nelson, MD, MPH

12. IPD Sharing Statement

Learn more about this trial

Orchidopexy Randomized Clinical Assessment

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