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Orchidopexy Randomized Clinical Assessment

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

Who can join

4 Months – 36 Months · Men

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.

About the study

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).

What is being tested

• Single-stage Fowler-Stephens orchidopexy (FSO) (procedure)
• Two-stage Fowler-Stephens orchidopexy (FSO) (procedure)

Sponsor: Boston Children's Hospital · Participants: 66 · Started: 2014-08

Contact the study team

• Badar Omar, BA · Phone: 617-919-6352

Official record on ClinicalTrials.gov — NCT02235623

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.