Status:

RECRUITING

Orchidopexy Randomized Clinical Assessment

Lead Sponsor:

Boston Children's Hospital

Conditions:

Unilateral Cryptorchidism

Eligibility:

MALE

4-36 years

Phase:

NA

Brief 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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

August 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

66 Patients enrolled

Trial Details

Trial ID

NCT02235623

Start Date

August 1 2014

End Date

December 31 2025

Last Update

January 22 2025

Active Locations (1)

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Boston Children's Hospital

Boston, Massachusetts, United States, 02115