跳至主要内容
临床试验/NCT01656369
NCT01656369已完成不适用

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

Mansoura University1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2007年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
1
主要终点
recurrence rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
16 Years 至 64 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •complete rectal prolapse

排除标准

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

研究组 & 干预措施

Group I delorme operation only.

Active Comparator

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.

干预措施: Group I: delorme operation only. (Procedure)

delorme operation with post anal repair

Active Comparator

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.

干预措施: delorme operation with post anal repair (Procedure)

结局指标

主要结局

recurrence rate

时间窗: one year postoperative

recurrence rate

次要结局

  • changes of bowel habit(early postoperative, after 1 year)
  • incontinence(30 day postoperative,and one year postoperative)
  • manometric study(one year postoperative)
  • complications(30 day postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayman El Nakeeb

mansoura university

Mansoura University

研究点 (1)

Loading locations...

相似试验