Unilateral Cryptorchidism Clinical Trial
— ORCAOfficial title:
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).
| Status | Recruiting |
| Enrollment | 66 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 4 Months to 36 Months |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Boston Children's Hospital | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Boston Children's Hospital |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the volume of the operated testis via ultrasound measurements. | 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. | 6-12 months after final FSO surgery |