Randomized Control Trial of Micronized Purified Flavonoid Fraction for Post Operative Treatment in Anal Fistula Surgery
- Conditions
- Anal Fistula
- Interventions
- Drug: PlaceboDrug: Micronized purified flavonoid fraction(Daflon 1000mg)
- Registration Number
- NCT06184438
- Lead Sponsor
- Taipei Medical University Shuang Ho Hospital
- Brief Summary
The aim of this study is to evaluate the effect of micronized purified flavonoid fraction on postoperative symptoms after surgery of anorectal fistulas.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- Patients who undergo fistulectomy or fistulotomy are included.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Placebo Received placebo after surgery from day 0 to day 7. Daflon group Micronized purified flavonoid fraction(Daflon 1000mg) Received Micronized purified flavonoid fraction(Daflon 1000mg) BID after surgery from day 0 to day 7.
- Primary Outcome Measures
Name Time Method Frequency of dressing replacement 0-7 days Record the frequency of dressing replacement from post-operative day 0 to day 7.
Post-operative pain 0-7 days Record the maximum pain score(visual analog scale, 0-10) from post-operative day 0 to day 7.
- Secondary Outcome Measures
Name Time Method Incidence of urinary retention 0-7days Urinary retention was defined as patients requiring Foley catheterization during the hospital stay.
Daily activity 0-7 days The number of days the patient takes to go back to work.
Patient satisfaction Post Operative day 7 Questionnaire will be collected after the surgery.
Incidence of surgical site infection 0-30 days Surgical site infection was defined as hospital admission for infection management or need for surgical intervention to manage the wound.
Bowel movement 0-7 days Duration until first bowel movement after surgery.
Wound healing questionnaire 0-60 days Evaluate wound healing at 30 days after operation.
Analgesic agent use 0-7days Daily consumption of oral analgesics from post-operative day 0 to day 7
Length of hospital stay 0-7 days Length of hospital stay after the surgery.
Trial Locations
- Locations (1)
Taipei Medical University Shuang-Ho Hospital
🇨🇳New Taipei City, Taiwan