Orchidopexy Randomized Clinical Assessment (ORCA)

Boston Children's Hospital

Status: Enrolling

Conditions: Unilateral Cryptorchidism

Treatments: Procedure: Single-stage Fowler-Stephens orchidopexy (FSO); Procedure: Two-stage Fowler-Stephens orchidopexy (FSO)

Study type: Interventional

Funder types: Other

Identifiers

NCT02235623

P00008033

Details and patient eligibility

About

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).

Enrollment: 66 estimated patients

Sex: Male

Ages: 4 to 36 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

66 participants in 2 patient groups

Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO)

Other group

Description:

Stage 1 single surgery to clip the vessels to the testis, divide the spermatic vessels and bring the testis into the scrotum.

Treatment:

Procedure: Single-stage Fowler-Stephens orchidopexy (FSO)

Stage 2- Two-stage Fowler-Stephens orchidopexy (FSO)

Other group

Description:

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.

Treatment:

Procedure: Two-stage Fowler-Stephens orchidopexy (FSO)