Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ayman elnakeeb, Mansoura University
ClinicalTrials.gov Identifier:
NCT01656369
First received: July 26, 2012
Last updated: August 4, 2012
Last verified: January 2007
  Purpose

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.


Condition Intervention
Rectal Prolapse
Procedure: Group I: delorme operation only.
Procedure: delorme operation with post anal repair

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparative Study Between Delorme Operation With or Without Postanal Repair and Levatorplasty in Treatment of Complete Rectal Prolapse.

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • recurrence rate [ Time Frame: one year postoperative ] [ Designated as safety issue: Yes ]
    recurrence rate


Secondary Outcome Measures:
  • changes of bowel habit [ Time Frame: early postoperative, after 1 year ] [ Designated as safety issue: Yes ]
    changes of bowel habit

  • incontinence [ Time Frame: 30 day postoperative,and one year postoperative ] [ Designated as safety issue: Yes ]
    incontinence

  • manometric study [ Time Frame: one year postoperative ] [ Designated as safety issue: Yes ]
    manometric study (resting pressure, squeezing pressure)

  • complications [ Time Frame: 30 day postoperative ] [ Designated as safety issue: Yes ]
    stricture, disruption


Enrollment: 82
Study Start Date: January 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group I delorme operation only.
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.
Procedure: Group I: delorme operation only.
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.
Other Name: Group I
Active Comparator: delorme operation with post anal repair
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.
Procedure: delorme operation with post anal repair
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.
Other Name: Group II

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.

  Eligibility

Ages Eligible for Study:   16 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656369

Locations
Egypt
Ayman El Nakeeb
Mansoura, Egypt
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: ayman el nakeeb, MD Mansoura University
  More Information

No publications provided by Mansoura University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ayman elnakeeb, mansoura university, Mansoura University
ClinicalTrials.gov Identifier: NCT01656369     History of Changes
Other Study ID Numbers: Rectal prolapse
Study First Received: July 26, 2012
Last Updated: August 4, 2012
Health Authority: Egypt: Institutional Review Board

Keywords provided by Mansoura University:
Delorme operation,incontinence

Additional relevant MeSH terms:
Prolapse
Rectal Prolapse
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Pelvic Organ Prolapse
Rectal Diseases

ClinicalTrials.gov processed this record on November 20, 2014