Fistulotomy With Marsupialization Versus Fistulectomy With Wound Sutures in Simple Anal Fistula, a Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- healing time
研究概览
简要总结
comparison between fistulectomy wound closure and fistulotomw wound marsupialization in treatment of simple anal fistula
详细描述
the investigators conducted this comparative clinical trial in the period between April 2017 and March 2019, on 92 patients with simple anal fistula, patients were randomly allocated into 2 groups, group I the fistulotomy group; 46 patients they underwent fistulotomy and marsupialization of wound edges. Group II, the fistulectomy group they underwent fistulectomy with closure of the wound.
Randomization was done using computer generated cards, the trial was approved by institutional review board (IRB) and the ethical committee of our hospitals, all study participants signed an informed written consent.
The condition of this trial is simple anal fistula defined as non-branched fistula confined to the lower third of the anal sphincter diagnosed by anorectal examination or MRI if needed, the primary outcomes are; the time taken for complete healing, fistula recurrence and anal incontinence diagnosed by Vaizey score patient's questionnaire. The secondary outcomes are local wound complications and postoperative pain calculated by visual analogue score (VAS). Study participants number was calculated through the IRB depending on the incidence of simple anal fistula in our locality.
inclusion criteria
• patients above 18 years diagnosed with simple non recurrent anal fistula.
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
the patients don't know which procedure they underwent
入排标准
- 年龄范围
- 18 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients above 18 years diagnosed with simple non recurrent anal fistula.
排除标准
- •Anorectal malignancy.
- •Specific disease (Crohn's disease).
- •ASA class III, VI and any contraindication for surgery
- •Immunocompromized patients and those on steroid therapy or cytotoxic drugs.
- •Perianal collection.
结局指标
主要结局
healing time
时间窗: 8 weeks
time taken for complete epithelialization of the wound detected by clinical examination
number of participants with recurrence of anal fistula
时间窗: 6 months
presence of anal fistula after complete wound healing detected by clinical examination
number of participants with anal incontinence
时间窗: i months
inability to control stool or flatus diagnosed by Vaizey score questionaire
次要结局
- number of participants with postoperative pain and its degree(1 week)
- number of participants with post operative complications(1 week)
- operative time(1 hour)
研究者
Hazem Nour Abdellatif
Assistant professor
Zagazig University