Orchidopexy Randomized Clinical Assessment

Launched by BOSTON CHILDREN'S HOSPITAL · Sep 8, 2014

Keywords

ClinConnect Summary

This clinical trial, called the Orchidopexy Randomized Clinical Assessment, is looking at two different surgical methods to fix an undescended testicle in boys. Specifically, it compares a single-stage surgery, where everything is done at once, to a two-stage surgery that takes place over two separate procedures. The goal is to see which method works better for the testicle's health, as well as to evaluate the costs, any complications from the surgeries, and how these procedures affect the overall quality of life for the boys involved. Doctors will check the testicle's condition using an ultrasound about 6 to 12 months after the surgery.

To be part of this trial, boys between 4 months and 36 months old who are undergoing a specific type of surgery called diagnostic laparoscopy for an undescended testicle may be eligible. This trial is currently recruiting participants, and the decision about which surgical method to use will be made by the attending surgeon based on the individual situation. Parents can expect that their child will receive close monitoring and care throughout the process, with results that could help improve treatment options for future patients with similar conditions.

Gender

MALE

Eligibility criteria

• 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.