Orchidopexy Randomized Clinical Assessment
| Status: | Recruiting |
|---|---|
| Conditions: | Urology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/24/2019 |
| Start Date: | August 2014 |
| End Date: | December 2020 |
| Contact: | Alyssia Venna, MBS |
| Email: | alyssia.venna@childrens.harvard.edu |
| Phone: | 617-919-6352 |
Randomized Trial of One Stage vs Two Stage Orchidopexy for Abdominal Undescended Testis
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).
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).
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.
We found this trial at
1
site
300 Longwood Ave
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Caleb P Nelson, MD, MPH
Phone: 617-919-6352
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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