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临床试验/NCT04351074
NCT04351074已完成不适用

Ligation of Intersphincteric Track (LIFT) Versus Fistulectomy in Trans-sphincteric Anal Fistula. Randomized Clinical Trial.

Zagazig University2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
2
主要终点
postoperative pain

研究概览

简要总结

78 patients with transsphincteric fistula allocated into two groups group A underwent LIFT group B u nderwent fistulectomy , comparison between the outcome og both procedures

详细描述

This randomized comparative clinical trial was carried out in Zagazig university hospitals, general surgery department, between March 2018 and February 2020, on 78 patients with transsphincteric anal fistula.

All patients were informed and signed a written consent for participation in this study, the study was approved by the local ethical committee of our university the sample size was calculated by the statistical unit of the local institutional review board participant selection; participant included in this study are those above 18 years old, suffering transsphincteric anal fistula diagnosed by clinical examination and magnetic resonant imaging (MRI) in doubtful cases, We excluded all patients with;

  • Anorectal malignancy.
  • Patient with previous radiotherapy to the region.
  • Those with fistula due to specific disease as Crohn's disease.
  • Patients with anal incontinence.
  • Patients with perianal collections.
  • Patients on cytotoxic or immunosuppressive therapy. Randomization; According to intervention,participants were randomly allocated using computer generated random numbers into two groups, group A (39 patients): Patients underwent intersphincteric ligation of fistulous track (LIFT) and group B (39 patients): Patients underwent fistulectomy.

Procedures ; All participants were subjected to full clinical examination including detailed history, formal digital rectal examination for assessment of anal sphincter integrity, identification of internal and external openings of the fistula, MRI was performed in those with doubtful clinical examination. Preoperative investigations performed according to American society of anesthesia (ASA) guidelines, all patients received 1 gm third generation cephalosporin with induction of anesthesia and continued for 24 hours postoperative, fleet enema was performed 12 hours and 2 hours before operation.

Surgical technique;

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
None

入排标准

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

入选标准

  • patients with transsphincteric anal fistula

排除标准

  • Anorectal malignancy.
  • Patient with previous radiotherapy to the region.
  • Those with fistula due to specific disease as Crohn's disease.
  • Patients with anal incontinence.
  • Patients with perianal collections.
  • Patients on cytotoxic or immunosuppressive therapy.

结局指标

主要结局

postoperative pain

时间窗: 1 day

degree of pain measured by patient questionnaire visual analogue scale(from 1 to 10) the high the score the more sever the pain is

incontinence

时间窗: 1 week

inability to control flatus or stool detected by Vaizy patient questionnaire

hospital stay

时间窗: 1 day

from admission to discharge measured in days

recurrence

时间窗: 8 weeks

recurrence of the fistula after complete healing of wound detected by clinical examination

operative time

时间窗: 1 hour

time from 1st incision to wound packing counted in minutes

次要结局

  • wound complications(1 week)

研究者

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

Hazem Nour Abdellatif

Assistant professor

Zagazig University

研究点 (2)

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