Pexy Versus Non-pexy for Full Thickness Rectal Prolapse
NCT ID: NCT01022034
Last Updated: 2009-12-02
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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COMPLETED
PHASE3
180 participants
INTERVENTIONAL
2003-01-31
2009-10-31
Brief Summary
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Method: This is a multicenter randomized non-inferiority trial. Eligible patients were randomized to no rectopexy or rectopexy. The no rectopexy arm was defined as abdominal surgery with rectal mobilization only. The rectopexy arm was defined as abdominal surgery with mobilization and pexy. Sigmoid resection was not randomized and was added in the presence of constipation. The endpoint was recurrence rates defined as presence of external FTRP after surgery. A pre-RCT meta-analysis suggested a sample size of 251 patients based on a 15% expected difference in the 5-year cumulative recurrence rate. Recurrence-free curves will be generated and compared using the Kaplan-Meier method and log-rank test, respectively. A Bonferroni adjustment was used. An adjusted p value of \<0.01 was considered significant.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pexy group
This group of patients with full thickness rectal prolapse will receive standard sacral rectopexy with mesh or sutures
sacral rectopexy with sutures or meshes
Non-pexy group
These patients will receive full rectal mobilization from the sacrum but without rectopexy
full rectal mobilization from the sacrum without sacral rectopexy
Interventions
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sacral rectopexy with sutures or meshes
full rectal mobilization from the sacrum without sacral rectopexy
Eligibility Criteria
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Inclusion Criteria
* mental ability to understand the procedure
* age range 18 to 70
* both sex
Exclusion Criteria
* previous pelvic or colorectal surgery
* previous operation for fecal incontinence
* Cancer
* chronic intestinal Inflammatory diseases
18 Years
70 Years
ALL
No
Sponsors
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Societa Italiana di Chirurgia ColoRettale
NETWORK
Responsible Party
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State Univeristy of New York , Stony Brook
Locations
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Stony brook University
New York, New York, United States
Countries
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Other Identifiers
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Berg.2007
Identifier Type: -
Identifier Source: org_study_id