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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

Minimum Age

4 Months

Maximum Age

36 Months

Download Date

May 12, 2021

Principal Investigator

Caleb Nelson

Primary Contact Information

Rachel Saunders, BA

617-355-4720

Rachel.Saunders@childrens.harvard.edu

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: