Randomized Control Trial of Micronized Purified Flavonoid Fraction for Post Operative Treatment in Anal Fistula Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Frequency of dressing replacement
研究概览
简要总结
The aim of this study is to evaluate the effect of micronized purified flavonoid fraction on postoperative symptoms after surgery of anorectal fistulas.
详细描述
The current theory of cryptoglandular suggest that perianal fistula occurs when the anal crypt glands become occluded and infected, over 90% of perianal fistulas are cryptoglandular in origin and arise from perianal abscesses. Also inflammatory process might play an important role in the formation of cryptoglandular perianal fistula. This condition is mainly managed with surgery, currently remain majorly on two conventional surgical interventions--fistulotomy and fistulectomy.
MPFF is a drug to treat venous vessel disease such as varicose and hemorrhoid, which was found with effects of lowering lymphatic permeability, improving venous return and vessel endothelial inflammation. More research has also shown the effects of MPFF on post hemorrhoidectomy symptom control, such as bleeding, pain, and infection. Since other anorectal surgery has similar complications. Therefor we conducted this randomized control trial to evaluate the benefits of MPFF after anal fistula surgeries.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo fistulectomy or fistulotomy are included.
排除标准
- •Emergency operation
- •Participants who had Trans-sphincteric anal fistula, Extra-sphincteric anal fistula
- •Participants accompanied by severe liver cirrhosis
- •Participants accompanied by coagulation disorders
- •Participants taking anticoagulant
- •Participants taking corticosteroids as long-term medication.
- •Participants who had colorectal cancer
- •Participants taking analgesic drugs (morphine or others) as long-term medication
- •Participants bed-ridden
- •Participants who had history of human immunodeficiency virus (HIV) infection
- •Pregnant woman
研究组 & 干预措施
Daflon group
Received Micronized purified flavonoid fraction(Daflon 1000mg) BID after surgery from day 0 to day 7.
干预措施: Micronized purified flavonoid fraction(Daflon 1000mg) (Drug)
Placebo group
Received placebo after surgery from day 0 to day 7.
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of dressing replacement
时间窗: 0-7 days
Record the frequency of dressing replacement from post-operative day 0 to day 7.
Post-operative pain
时间窗: 0-7 days
Record the maximum pain score(visual analog scale, 0-10) from post-operative day 0 to day 7.
次要结局
- Incidence of urinary retention(0-7days)
- Daily activity(0-7 days)
- Patient satisfaction(Post Operative day 7)
- Incidence of surgical site infection(0-30 days)
- Bowel movement(0-7 days)
- Wound healing questionnaire(0-60 days)
- Analgesic agent use(0-7days)
- Length of hospital stay(0-7 days)
研究者
Tungcheng Chang, MD, PhD
Chief of Colorectal Surgery
Taipei Medical University Shuang Ho Hospital