Comparative Study Between Delorme Operation With or Without Postanal Repair in Treatment of Complete Rectal Prolapse

Not Applicable

Completed

• Conditions: Rectal Prolapse

• Registration Number: NCT01656369
• Lead Sponsor: Mansoura University

Brief Summary

The aim of the study is to compare Delorme operation alone or with post anal repair and levatorplasty for treating complete rectal prolapse.consecutive patients who were treated for complete rectal prolapse at the Colorectal Surgery Unit were eligible for the study.The patients were randomized into two groups: Group I: consisted of patients were subjected to delorme operation only. Group II: consisted of patients were subjected to delorme operation with post anal repair and levatorplasty.

Detailed Description

Rectal procidentia frequently occurs in older women. Patients usually present with obstructed defecation or fecal incontinence. This study is to compare Delorme operation alone or with post anal repair and levatorplasty for treating complete rectal prolapse. Consecutive patients who were treated for complete rectal prolapse at our Colorectal Surgery Unit were eligible for the study. Exclusion criteria include pregnant female, any patients with previous anal surgery, pudendal nerve neuropathy, anal fistula and sepsis or coagulopathy. All patients underwent clinical evaluation, proctoscopic examination, and sigmoidoscopy. Anorectal physiology studies consisted of anal manometry and measurement of pudendal nerve terminal motor latency (PNTML) to exclude pudendal nerve entrapment syndrome. Patients enrolled in the study were randomized into three groups using the closed envelope method. The envelopes were drawn and opened by a nurse not otherwise engaged in the study in the operating room. The patients were randomized into two groups: Group I: consisted of patients were subjected to delorme operation only. Group II: consisted of patients were subjected to delorme operation with post anal repair and levatorplasty.

Study Timeline

• Status Verified: 2007-01
• Study Start: 2007-01
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2012-07-26
• Study First Submitted QC: 2012-08-02
• Study First Posted: 2012-08-03
• Last Update Submitted: 2015-11-20
• Last Update Posted: 2015-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• complete rectal prolapse

Exclusion Criteria

• pregnant female
• any patients with previous anal surgery
• pudendal nerve neuropathy
• anal fistula and sepsis or coagulopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
recurrence rate	one year postoperative	recurrence rate

Secondary Outcome Measures

Name	Time	Method
changes of bowel habit	early postoperative, after 1 year	changes of bowel habit
incontinence	30 day postoperative,and one year postoperative	incontinence
manometric study	one year postoperative	manometric study (resting pressure, squeezing pressure)
complications	30 day postoperative	stricture, disruption

Trial Locations

Locations (1)

Ayman El Nakeeb; 🇪🇬 Mansoura, Egypt