Orchidopexy Randomized Clinical Assessment

Description

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).

Conditions

Unilateral Cryptorchidism

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Study Overview

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Study Details

Study overview

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).

Randomized Trial of One Stage vs Two Stage Orchidopexy for Abdominal Undescended Testis

Orchidopexy Randomized Clinical Assessment

Condition
Unilateral Cryptorchidism
Intervention / Treatment

-

Contacts and Locations

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

4 Months to 36 Months

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Children's Hospital,

Caleb P Nelson, MD, MPH, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

2024-12-31