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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparative Study Between Delorme Operation With or Without Postanal Repair and Levatorplasty in Treatment of Complete Rectal Prolapse.

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 Summary: 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.
Sponsor: Mansoura University

Current Primary Outcome: recurrence rate [ Time Frame: one year postoperative ]

recurrence rate


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • changes of bowel habit [ Time Frame: early postoperative, after 1 year ]
    changes of bowel habit
  • incontinence [ Time Frame: 30 day postoperative,and one year postoperative ]
    incontinence
  • manometric study [ Time Frame: one year postoperative ]
    manometric study (resting pressure, squeezing pressure)
  • complications [ Time Frame: 30 day postoperative ]
    stricture, disruption


Original Secondary Outcome: Same as current

Information By: Mansoura University

Dates:
Date Received: July 26, 2012
Date Started: January 2007
Date Completion:
Last Updated: November 20, 2015
Last Verified: January 2007