Clinical Trial: Orchidopexy Randomized Clinical Assessment

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 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).

Detailed Summary:
Sponsor: Boston Children’s Hospital

Current Primary Outcome: To evaluate the volume of the operated testis via ultrasound measurements. [ Time Frame: 6-12 months after final FSO surgery ]

To evaluate the volume of the operated testis at 6-12 months after single-stage Fowler-Stephens orchidopexy (FSO) (6-12 months after two- stage FSO), as determined by ultrasound measurements. This will be compared to the intra-operative testicular measurements done during the laparoscopy.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Boston Children’s Hospital

Dates:
Date Received: September 2, 2014
Date Started: August 2014
Date Completion: December 2018
Last Updated: January 30, 2017
Last Verified: August 2016