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

Taipei Medical University

Status and phase: Completed; Phase 4

Conditions: Anal Fistula

Treatments: Drug: Micronized purified flavonoid fraction(Daflon 1000mg); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06184438

N202309013

Details and patient eligibility

About

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

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who undergo fistulectomy or fistulotomy are included.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups, including a placebo group

Daflon group

Experimental group

Description:

Received Micronized purified flavonoid fraction(Daflon 1000mg) BID after surgery from day 0 to day 7.

Treatment:

Drug: Micronized purified flavonoid fraction(Daflon 1000mg)

Placebo group

Placebo Comparator group

Description:

Received placebo after surgery from day 0 to day 7.

Treatment:

Drug: Placebo