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).
Conditions
Unilateral Cryptorchidism
Recruitment Status
Recruiting
Eligibility Criteria
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.
Intervention
Intervention Type
Intervention Name
Procedure
Single-stage Fowler-Stephens orchidopexy (FSO)
Procedure
Two-stage Fowler-Stephens orchidopexy (FSO)
Phase
Not Applicable
Gender
Male
Min Age
4 Months
Max Age
36 Months
Download Date
February 9, 2024
Principal Investigator
Caleb Nelson
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: