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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO) | Other | Stage 1 single surgery to clip the vessels to the testis, divide the spermatic vessels and bring the testis into the scrotum. |
|
| Stage 2- Two-stage Fowler-Stephens orchidopexy (FSO) | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-stage Fowler-Stephens orchidopexy (FSO) | Procedure |
| ||
| Two-stage Fowler-Stephens orchidopexy (FSO) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Badar Omar, BA | Contact | 617-919-6352 | Badar.Omar@childrens.harvard.edu | |
| Vera Rodic, MPH | Contact | Vera.Rodic@childrens.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Caleb P Nelson, MD, MPH | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D003456 | Cryptorchidism |
| ID | Term |
|---|---|
| D013733 | Testicular Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Procedure |
|
| D052801 |
| Male Urogenital Diseases |
| D014564 | Urogenital Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |