Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-27 @ 11:25 PM
Study NCT ID:
NCT01022034
Status:
COMPLETED
Last Update Posted:
2009-12-02
First Post:
2009-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pexy Versus Non-pexy for Full Thickness Rectal Prolapse
Sponsor:
Societa Italiana di Chirurgia ColoRettale
Organization:
Study Overview
Official Title:
Pexy vs. No Pexy in Abdominal Surgery for Full Thickness Rectal Prolapse in Adults: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Bergamaschi
Brief Summary:
No randomized controlled trial (RCT) has compared no rectopexy to rectopexy for external full-thickness rectal prolapse (FTRP). This study was performed to test the hypothesis that recurrence rates for FTRP following no rectopexy are not inferior to those for rectopexy.
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.
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:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: