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

Primary Purpose

Rectal Prolapse

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Group I: delorme operation only.
delorme operation with post anal repair
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Prolapse focused on measuring Delorme operation,incontinence

Eligibility Criteria

16 Years - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • complete rectal prolapse

Exclusion Criteria:

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

Sites / Locations

  • Ayman El Nakeeb

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group I delorme operation only.

delorme operation with post anal repair

Arm Description

A circumferential incision was made in the rectal mucosa approximately 1 cm away from the dentate line. Using electrocautery, the mucosa was stripped to the apex of the prolapse. The muscular layers of the rectal wall were reduced as the mucosa was stripped. Mucosal stripping continued past the apex of the prolapse and then continued inside the prolapsed segment to a point internally that is equivalent to the point of the initial mucosal incision. The underling muscle was plicated by vicryl 2/0.The muscle bite was taken longitudinally from 8 sides to reach a horizontal line of plication at the end. The mucosa was then reanastomosed. Postoperatively, minimal pain medication was required. Early ambulation was encouraged, and patients' diets were advanced as tolerated.

In group II : post anal repair was added by making transverse incision 7cm behind the anal canal.dissection of intersphincteric plain,plication of internal sphincter by using 3/0 vicryl.The levator ani and external sphincter were then sutured to each other by vicryl 2/0 behind the anal canal followed by skin closure without drain.

Outcomes

Primary Outcome Measures

recurrence rate
recurrence rate

Secondary Outcome Measures

changes of bowel habit
changes of bowel habit
incontinence
incontinence
manometric study
manometric study (resting pressure, squeezing pressure)
complications
stricture, disruption

Full Information

First Posted
July 26, 2012
Last Updated
November 20, 2015
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT01656369
Brief Title
Comparative Study Between Delorme Operation With or Without Postanal Repair in Treatment of Complete Rectal Prolapse
Official Title
Comparative Study Between Delorme Operation With or Without Postanal Repair and Levatorplasty in Treatment of Complete Rectal Prolapse.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Prolapse
Keywords
Delorme operation,incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I delorme operation only.
Arm Type
Active Comparator
Arm Description
A circumferential incision was made in the rectal mucosa approximately 1 cm away from the dentate line. Using electrocautery, the mucosa was stripped to the apex of the prolapse. The muscular layers of the rectal wall were reduced as the mucosa was stripped. Mucosal stripping continued past the apex of the prolapse and then continued inside the prolapsed segment to a point internally that is equivalent to the point of the initial mucosal incision. The underling muscle was plicated by vicryl 2/0.The muscle bite was taken longitudinally from 8 sides to reach a horizontal line of plication at the end. The mucosa was then reanastomosed. Postoperatively, minimal pain medication was required. Early ambulation was encouraged, and patients' diets were advanced as tolerated.
Arm Title
delorme operation with post anal repair
Arm Type
Active Comparator
Arm Description
In group II : post anal repair was added by making transverse incision 7cm behind the anal canal.dissection of intersphincteric plain,plication of internal sphincter by using 3/0 vicryl.The levator ani and external sphincter were then sutured to each other by vicryl 2/0 behind the anal canal followed by skin closure without drain.
Intervention Type
Procedure
Intervention Name(s)
Group I: delorme operation only.
Other Intervention Name(s)
Group I
Intervention Description
A circumferential incision was made in the rectal mucosa approximately 1 cm away from the dentate line. Using electrocautery, the mucosa was stripped to the apex of the prolapse. The muscular layers of the rectal wall were reduced as the mucosa was stripped. Mucosal stripping continued past the apex of the prolapse and then continued inside the prolapsed segment to a point internally that is equivalent to the point of the initial mucosal incision. The underling muscle was plicated by vicryl 2/0.The muscle bite was taken longitudinally from 8 sides to reach a horizontal line of plication at the end. The mucosa was then reanastomosed.
Intervention Type
Procedure
Intervention Name(s)
delorme operation with post anal repair
Other Intervention Name(s)
Group II
Intervention Description
In group II : post anal repair was added by making transverse incision 7cm behind the anal canal.dissection of intersphincteric plain,plication of internal sphincter by using 3/0 vicryl.The levator ani and external sphincter were then sutured to each other by vicryl 2/0 behind the anal canal followed by skin closure without drain.
Primary Outcome Measure Information:
Title
recurrence rate
Description
recurrence rate
Time Frame
one year postoperative
Secondary Outcome Measure Information:
Title
changes of bowel habit
Description
changes of bowel habit
Time Frame
early postoperative, after 1 year
Title
incontinence
Description
incontinence
Time Frame
30 day postoperative,and one year postoperative
Title
manometric study
Description
manometric study (resting pressure, squeezing pressure)
Time Frame
one year postoperative
Title
complications
Description
stricture, disruption
Time Frame
30 day postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: complete rectal prolapse Exclusion Criteria: pregnant female any patients with previous anal surgery pudendal nerve neuropathy anal fistula and sepsis or coagulopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ayman el nakeeb, MD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayman El Nakeeb
City
Mansoura
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
23187047
Citation
Youssef M, Thabet W, El Nakeeb A, Magdy A, Alla EA, El Nabeey MA, Fouda el Y, Omar W, Farid M. Comparative study between Delorme operation with or without postanal repair and levateroplasty in treatment of complete rectal prolapse. Int J Surg. 2013;11(1):52-8. doi: 10.1016/j.ijsu.2012.11.011. Epub 2012 Nov 24.
Results Reference
derived
Links:
URL
http://www.mans.edu.eg/
Description
Mansoura university

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

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