Orchidopexy Randomized Clinical Assessment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single-stage Fowler-Stephens orchidopexy (FSO), Two-stage Fowler-Stephens orchidopexy (FSO).
- Who it may be relevant to
- Registry conditions: Unilateral Cryptorchidism. Basic parameters: 4 months — 36 months · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Trial of One Stage vs Two Stage Orchidopexy for Abdominal Undescended Testis
Overview
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).
Interventions
- Procedure Single-stage Fowler-Stephens orchidopexy (FSO)
- Procedure Two-stage Fowler-Stephens orchidopexy (FSO)
Primary outcome measures
- To evaluate the volume of the operated testis via ultrasound measurements. [Time frame: 6-12 months after final FSO surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Boston Children's Hospital — Boston
Identifiers
NCT: NCT02235623 · P00008033