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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-13

Study Completion Date

2025-03-31

Brief Summary

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

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Detailed Description

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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

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Anal Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

We designed a randomized controlled trial including 150 eligible patients who underwent fistulotomy or fistulectomy. To evaluate the benefit of using MPFF after fistula surgery, patients were classified into 2 groups:

1. Received MPFF(Daflon 1000mg BID) after surgery.
2. Received placebo after surgery.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Daflon group

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

Group Type EXPERIMENTAL

Micronized purified flavonoid fraction(Daflon 1000mg)

Intervention Type DRUG

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

Placebo group

Received placebo after surgery from day 0 to day 7.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Received placebo after surgery.

Interventions

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Micronized purified flavonoid fraction(Daflon 1000mg)

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

Intervention Type DRUG

Placebo

Received placebo after surgery.

Intervention Type DRUG

Other Intervention Names

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diosmin hesperidin Control group

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No