Orchidopexy Randomized Clinical Assessment

  • STATUS
    Recruiting
  • End date
    Dec 24, 2023
  • participants needed
    66
  • sponsor
    Boston Children's Hospital
Updated on 24 May 2021

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).

Details
Condition Undescended testicle
Treatment Single-stage Fowler-Stephens orchidopexy (FSO), Two-stage Fowler-Stephens orchidopexy (FSO)
Clinical Study IdentifierNCT02235623
SponsorBoston Children's Hospital
Last Modified on24 May 2021

Eligibility

Yes No Not Sure

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
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