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临床试验/NCT04155905
NCT04155905已完成不适用

Fistulotomy Versus Fistulotomy With Marsupialization of Wound Edges in Simple Perianal Fistula, a Comparative Clinical Trial

Zagazig University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年5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
70
试验地点
2
主要终点
operative time in minutes

研究概览

简要总结

comparison between to groups of patients with simple anal fistula one group underwent sistulotomy the other underwent fistulotomy and marsupialization of the wound edges , the investigator tested the incidence of postoperative complications , time of wound healing , operative time

详细描述

This randomized controlled trial was carried in the period between May 2018 and April 2019, on 70 patients undergoing fistulotomy for treatment of simple perianal fistula. Patients were randomly allocated into two equal groups each 35 patients, group A; underwent fistulotomy without marsupialization of the edges of fistulotomy wound. And group B; underwent fistulotomy with marsupialization of the wound edges.

Patients included in this study are those suffering simple non recurrent perianal fistula with ASA I and II.

the investigator excluded patients with secondary anal fistula, complex fistula, anal incontinence, previous anal surgery and any disease or drug that affects wound healing.

All patients were subjected to thorough history taking and careful anal examination to assess the sphincter integrity, define the fistulous track and internal opening, endo anal ultrasound or magnetic resonance imaging was ordered when needed.

Fistulotomy was done under spinal anesthesia in the lithotomy position after skin preparation and patient draping; anal examination under anesthesia was done, identification of the internal opening carried out using palpation and inspection using proctoscope, injection of hydrogen peroxide in the external opening done if internal opening couldn't be defined easily, then the fistulous track was probed, it was laid open using diathermy, in group B the wounds was marsupialized by suturing the skin edges to the edges of the track floor using absorbable sutures (polygalactin) 3\0. Figures (1) and (2) shows the probed fistulous track and its' wound after marsupialization.

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)

盲法说明

patients don't know the procedure

入排标准

性别
All
接受健康志愿者

入选标准

  • Simple non recurrent perianal fistula with ASA I and II.

排除标准

  • secondary anal fistula,
  • complex fistula,
  • anal incontinence,
  • previous anal surgery
  • Any disease or drug that affects wound healing.

结局指标

主要结局

operative time in minutes

时间窗: intraoperative

the time taken for completion of the procedure from fistulous track identification to the end of fistulotomy or marsupialization

wound healing time

时间窗: 1 year

time taken for wound to be completely healed

postoperative pain using visual analogue scale

时间窗: 1 week

pain in the postoperative period

postoperative complications measured by clinical examination and anal sphincter manometry

时间窗: 1 year

examination of the patient for fistula recurrence, history, clinical examination and anal sphincter manometry for anal incontinence

次要结局

未报告次要终点

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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