Orchidopexy Randomized Clinical Assessment

Conditions

• Unilateral Cryptorchidism

Eligibility Criteria

Sex

MALE

Age

4 Months - 36 Months

Healthy Volunteers

Not accepted

Interventions

• Single-stage Fowler-Stephens orchidopexy (FSO) — PROCEDURE
• Two-stage Fowler-Stephens orchidopexy (FSO) — PROCEDURE

Study Details

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).

Key Dates

Start date

Aug 31, 2014

Status verified

Apr 2026

Primary completion

Dec 31, 2030

Completion

Dec 31, 2030

Study Design

Enrollment

66 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO)
  Stage 1 single surgery to clip the vessels to the testis, divide the spermatic vessels and bring the testis into the scrotum.
• Other: Stage 2- Two-stage Fowler-Stephens orchidopexy (FSO)
  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.

Primary Outcome Measure

To evaluate the volume of the operated testis via ultrasound measurements. [ Time Frame: 6-12 months after final FSO surgery ]

Central Contacts

• Badar Omar, BA
  617-919-6352
  [email protected]
• Vera Rodic, MPH
  [email protected]

Locations (1)

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