Short-Term Outcome of Medical Vs. Surgical Management Of Chronic Anal Fissure (A Randomized Controlled Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- REALISE score
研究概览
简要总结
Several topical agents have been proposed for Chronic anal fissure (CAF) treatment with the common goal of increasing anodermal blood flow to promote healing but approaching the use of medical treatment in CAFs is not standardized yet. Thus, the present study aimed to compare the efficacy and safety of Sucralfate (Emoflon®), the combination of azadirachtin and hyperforin (HyperOil®) and the traditional surgical treatment (lateral sphincterotomy) in patients with CAFs.
详细描述
Several topical agents have been proposed for Chronic anal fissure (CAF) treatment with the common goal of increasing anodermal blood flow to promote healing but approaching the use of medical treatment in CAFs is not standardized yet. Thus, the present study aimed to compare the efficacy and safety of Sucralfate (Emoflon®), the combination of azadirachtin and hyperforin (HyperOil®) and the traditional surgical treatment (lateral sphincterotomy) in patients with CAFs.
Study Objective:
Primary Objectives:
- To evaluate the efficacy and safety of Sucralfate (Emoflon®), the combination of azadirachtin and hyperforin (HyperOil®) and the traditional surgical treatment (lateral sphincterotomy) in patients with CAFs.
Study Design:
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
- 否
入选标准
- •above 18 years old.
- •CAFs for the first time
- •ASA I, II
排除标准
- •Previous pelvic radiation.
- •recurrent chronic anal fissure
- •Pregnancy or lactation.
- •Immunosuppressive state
- •Malignancy
- •Refusal to participate
研究组 & 干预措施
Sucralfate Group
patients assigned to this group will start to use a topical rectal ointment containing Sucralfate. The patients are instructed to apply it twice a day, using a gloved finger, inside the anal canal and the perianal region for 40 days. the follow-up visits are arranged at 15, 30 and 40 days.
干预措施: Sucralfate (Drug)
HyperOil Group
patients assigned to this group will start to use topical oil containing the combination of azadirachtin and hyperforin. The patients are instructed to apply it twice a day, using a gloved finger, inside the anal canal and the perianal region for 40 days. the follow-up visits are arranged at 15, 30 and 40 days.
干预措施: Azadirachtin (Drug)
Surgery
patients assigned to this group will be operated for fissurectomy and lateral sphincterectomy. the follow-up visits are arranged at 15, 30 and 40 days.
干预措施: fissurectomy and lateral sphincterectomy (Procedure)
结局指标
主要结局
REALISE score
时间窗: in each 3 follow up visits (visit 1,2, and 3 after 15, 30 , and 40 days respectively)
REALISE (scoRing systEm for AnaL fIsSurE), will be used to assess pain (score range 0-10), quality of life, duration of pain, intake of analgesics and bleeding. The latter four items were rated on a scale of 1-5
次要结局
未报告次要终点
研究者
Waleed Ghareeb
Senior consultant and lecturer of General surgery
Suez Canal University