Orchidopexy Randomized Clinical Assessment

Not Applicable

Recruiting

• Conditions: Unilateral Cryptorchidism
• Interventions: Procedure: Single-stage Fowler-Stephens orchidopexy (FSO); Procedure: Two-stage Fowler-Stephens orchidopexy (FSO)

• Registration Number: NCT02235623
• Lead Sponsor: Boston Children's Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-08
• Study First Posted: 2014-09-10
• Status Verified: 2024-02
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO)	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.
Stage 2- Two-stage Fowler-Stephens orchidopexy (FSO)	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.

Primary Outcome Measures

Name	Time	Method
To evaluate the volume of the operated testis via ultrasound measurements.	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.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States