Orchidopexy Randomized Clinical Assessment

Study Overview
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Brief Summary
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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).

Official Title
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Randomized Trial of One Stage vs Two Stage Orchidopexy for Abdominal Undescended Testis

Conditions
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Unilateral Cryptorchidism

Intervention / Treatment
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* Procedure: Single-stage Fowler-Stephens orchidopexy (FSO)
* Procedure: Two-stage Fowler-Stephens orchidopexy (FSO)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO)<br>Stage 1 single surgery to clip the vessels to the testis, divide the spermatic vessels and bring the testis into the scrotum. | Procedure: Single-stage Fowler-Stephens orchidopexy (FSO)<br> <br> |
| Other: Stage 2- Two-stage Fowler-Stephens orchidopexy (FSO)<br>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. | Procedure: Two-stage Fowler-Stephens orchidopexy (FSO)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the volume of the operated testis via ultrasound measurements. | 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. | 6-12 months after final FSO surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Surgery, Orchiopexy