Clinical trial NCT01656369: 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
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Prolapse
Keywords: Delorme operation,incontinence
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2012-08-03
Enrollment: 82
Sex: ALL
Minimum age (years): 16
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: recurrence rate
timeFrame: one year postoperative
Secondary outcomes:
measure: changes of bowel habit
timeFrame: early postoperative, after 1 year
measure: incontinence
timeFrame: 30 day postoperative,and one year postoperative
measure: manometric study
timeFrame: one year postoperative
measure: complications
timeFrame: 30 day postoperative
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Ayman El Nakeeb
Study officials:
affiliation: Mansoura University
name: ayman el nakeeb, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.