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NCT02235623NARecruiting

Orchidopexy Randomized Clinical Assessment

Boston Children's Hospital

Start Date

8/1/2014

Completion Date

12/31/2030

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).

Eligibility Criteria

Age Range: No minimum to No maximum

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.

Interventions

PROCEDURE

Single-stage Fowler-Stephens orchidopexy (FSO)

PROCEDURE

Two-stage Fowler-Stephens orchidopexy (FSO)

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Conditions

Unilateral Cryptorchidism

Locations

Boston Children's Hospital

Boston, Massachusetts 02115

United States