One surgery or two? trial tests best fix for hidden testicle
NCT ID NCT02235623
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two surgical methods to fix a testicle that hasn't dropped into the scrotum and is located in the abdomen. Boys aged 4 months to 3 years with one undescended testicle will be randomly assigned to either a single surgery or a two-stage procedure. Researchers will measure testicle size, costs, complications, and quality of life to see which approach works better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Surgical procedure (Fowler-Stephens orchidopexy)
- What this could lead to
- If successful, this could show which surgical approach better preserves testicular health and reduces complications for boys with this condition.
- What could go wrong
- This is a small, early-stage trial with only 66 participants, so results may not apply to all cases. Both surgeries carry standard surgical risks like infection or bleeding.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Aug 2014
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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4 to 36 months
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Boston Children's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States