Fistulotomy Versus Fistulotomy With Marsupialization of Wound Edges in Simple Perianal Fistula, a Comparative Clinical Trial
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
- 否
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
Hazem Nour Abdellatif
Assistant professor
Zagazig University
