Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2014-08-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Single-stage Fowler-Stephens orchidopexy (FSO)
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.
Two-stage Fowler-Stephens orchidopexy (FSO)
Interventions
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Single-stage Fowler-Stephens orchidopexy (FSO)
Two-stage Fowler-Stephens orchidopexy (FSO)
Eligibility Criteria
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Inclusion Criteria
* 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 \< 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.
4 Months
36 Months
MALE
No
Sponsors
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Boston Children's Hospital
OTHER
Responsible Party
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Caleb Nelson
Caleb Nelson, MD MPH
Principal Investigators
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Caleb P Nelson, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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P00008033
Identifier Type: -
Identifier Source: org_study_id
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