Orchidopexy Randomized Clinical Assessment

NCT ID: NCT02235623

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Unilateral Cryptorchidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Single-stage Fowler-Stephens orchidopexy (FSO)

Intervention Type PROCEDURE

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.

Group Type OTHER

Two-stage Fowler-Stephens orchidopexy (FSO)

Intervention Type PROCEDURE

Interventions

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Single-stage Fowler-Stephens orchidopexy (FSO)

Intervention Type PROCEDURE

Two-stage Fowler-Stephens orchidopexy (FSO)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

4 Months

Maximum Eligible Age

36 Months

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Caleb Nelson

Caleb Nelson, MD MPH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Caleb P Nelson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Badar Omar, BA

Role: CONTACT

617-919-6352

Facility Contacts

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Badar Omar, BA

Role: primary

617-919-6354

Other Identifiers

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P00008033

Identifier Type: -

Identifier Source: org_study_id

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