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Completed

NCT Number: NCT06184438

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

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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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Taipei Medical University Shuang-Ho Hospital

New Taipei City, 235, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Micronized purified flavonoid fraction(Daflon 1000mg)

Drug

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

Other names: diosmin, hesperidin

Placebo

Drug

Received placebo after surgery.

Other names: Control group

Primary outcomes

  1. Post-operative pain

    Time frame: 0-7 days

    Record the maximum pain score(visual analog scale, 0-10) from post-operative day 0 to day 7.

  2. Frequency of dressing replacement

    Time frame: 0-7 days

    Record the frequency of dressing replacement from post-operative day 0 to day 7.

Secondary outcomes

  1. Analgesic agent use

    Time frame: 0-7days

    Daily consumption of oral analgesics from post-operative day 0 to day 7

  2. Incidence of surgical site infection

    Time frame: 0-30 days

    Surgical site infection was defined as hospital admission for infection management or need for surgical intervention to manage the wound.

  3. Incidence of urinary retention

    Time frame: 0-7days

    Urinary retention was defined as patients requiring Foley catheterization during the hospital stay.

  4. Daily activity

    Time frame: 0-7 days

    The number of days the patient takes to go back to work.

  5. Bowel movement

    Time frame: 0-7 days

    Duration until first bowel movement after surgery.

  6. Patient satisfaction

    Time frame: Post Operative day 7

    Questionnaire will be collected after the surgery.

  7. Length of hospital stay

    Time frame: 0-7 days

    Length of hospital stay after the surgery.

  8. Wound healing questionnaire

    Time frame: 0-60 days

    Evaluate wound healing at 30 days after operation.

Sponsors and collaborators

Lead sponsor

Taipei Medical University Shuang Ho Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 28, 2023
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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