Unilateral Cryptorchidism
Conditions
Keywords
Laparoscopic Surgery, Orchiopexy
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).
Interventions
PROCEDURESingle-stage Fowler-Stephens orchidopexy (FSO)
PROCEDURETwo-stage Fowler-Stephens orchidopexy (FSO)
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
4 Months to 36 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the volume of the operated testis via ultrasound measurements. | 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. |
Countries
United States
Contacts
CONTACTBadar Omar, BA
CONTACTVera Rodic, MPH
PRINCIPAL_INVESTIGATORCaleb P Nelson, MD, MPH
Boston Children's Hospital
Outcome results
None listed