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

Last updated: May 13, 2025
Sponsor: Taipei Medical University Shuang Ho Hospital
Overall Status: Completed

Phase

4

Condition

Rectal Disorders

Treatment

Placebo

Micronized purified flavonoid fraction(Daflon 1000mg)

Clinical Study ID

NCT06184438
N202309013
  • Ages 20-85
  • All Genders

Study Summary

The aim of this study is to evaluate the effect of micronized purified flavonoid fraction on postoperative symptoms after surgery of anorectal fistulas.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who undergo fistulectomy or fistulotomy are included.

Exclusion

Exclusion Criteria:

  • 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

Total Participants: 106
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
December 13, 2023
Estimated Completion Date:
March 31, 2025

Study 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.

Connect with a study center

  • Taipei Medical University Shuang-Ho Hospital

    New Taipei City, 235
    Taiwan

    Site Not Available

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