NCT06184438

Randomized Control Trial of Micronized Purified Flavonoid Fraction for Post Operative Treatment in Anal Fistula Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Taipei Medical University Shuang Ho Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anal Fistula

Interventions

Type	Name	Description
DRUG	Micronized purified flavonoid fraction(Daflon 1000mg)	Received Micronized purified flavonoid fraction(Daflon 1000mg) BID after surgery from day to day 7
DRUG	Placebo	Received placebo after surgery.

Timeline

• Start date: 2023-12-13
• Primary completion: 2025-01-01
• Completion: 2025-03-31
• First posted: 2023-12-28
• Last updated: 2025-05-16

Locations

1 site across 1 country: Taiwan