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临床试验/NCT01021774
NCT01021774已完成不适用

Comparison of Anal Fistula Treatment Outcome - Collagen Plug vs Advancement Flap Surgery. A Randomised Prospective Blinded Multi-centre Study

University Hospital, Akershus2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2009年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
94
试验地点
2
主要终点
Anorectal fistula closing rate

研究概览

简要总结

The purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap.

详细描述

Perianal fistula can occur as a complication to a perianal abscess. A perianal fistula is associated with significant morbidity and reduced quality of life. Anal fistulas seldom heal spontaneously and may require surgical intervention. The main purpose of the operation will be to close the fistula and preserve anal continence. The traditional surgical fistula closing techniques often show disappointing results. Today, a collagen plug for fistula treatment is commercially available. The mounting of this plug is technically easy and less invasive than the traditional closure of the fistula by making a lid of anal mucosa (advancement flap). The purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap, with regard to healing of fistula, anal continence and pain. Plug treatment has so far shown promising results, but prospective, randomised controlled trials are needed.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with fistula involving > 1/3 of the external anal sphincter
  • Single, continuous fistula tract at time of inclusion (implies pre-treatment with seton)
  • Patients with previous fistula surgery can be included (max. 1 lambeau or 1 plug)
  • All patients included must be able to fill in an informed, written consent and to understand its implications and contents and to participate in the follow-up

排除标准

  • Fistula tract shorter than 2 cm
  • Complex fistula tract system (branching of the fistula tract)
  • Age < 18 years
  • Pregnancy
  • HIV-positivity
  • Fistula caused by malignancy
  • Tuberculosis
  • Hidrosadenitis suppurativa
  • Pilonidal sinus disease
  • No internal fistula opening found
  • Unable/contra indications to go through MRI scanning
  • Crohn´s disease
  • Ulcerative proctitis

结局指标

主要结局

Anorectal fistula closing rate

时间窗: 1 year

次要结局

  • Quality of life(1 year)

研究者

发起方
University Hospital, Akershus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tom Oresland

Professor

University Hospital, Akershus

研究点 (2)

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