Randomized Trial of One Stage vs Two Stage Orchidopexy for Abdominal Undescended Testis
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 4 months
Maximum Age: 3
Healthy Volunteers: f
View:
• 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.
Locations
United States
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Contact Information
Primary
Badar Omar, BA
Badar.Omar@childrens.harvard.edu
617-919-6352
Time Frame
Start Date: 2014-08
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 66
Treatments
Other: Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO)
Stage 1 single surgery to clip the vessels to the testis, divide the spermatic vessels and bring the testis into the scrotum.
Other: Stage 2- Two-stage Fowler-Stephens orchidopexy (FSO)
Stage 2 2 surgeries: 1st surgery-Clip vessels to testis. 2nd surgery done 6-12 months later, divide the spermatic vessels and bring the testis into the scrotum.
Related Therapeutic Areas
Sponsors
Leads: Boston Children's Hospital