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

April 17, 2024 updated by: Tungcheng Chang, MD, PhD, Taipei Medical University Shuang Ho Hospital
The aim of this study is to evaluate the effect of micronized purified flavonoid fraction on postoperative symptoms after surgery of anorectal fistulas.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 235
        • Recruiting
        • Taipei Medical University Shuang-Ho Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Daflon group
Received Micronized purified flavonoid fraction(Daflon 1000mg) BID after surgery from day 0 to day 7.
Drug: Micronized purified flavonoid fraction(Daflon 1000mg)
Received Micronized purified flavonoid fraction(Daflon 1000mg) BID after surgery from day to day 7
Other Names:
  • diosmin
  • hesperidin
Placebo Comparator: Placebo group
Received placebo after surgery from day 0 to day 7.
Drug: Placebo
Received placebo after surgery.
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-7 days
Frequency of dressing replacement
Time Frame: 0-7 days
Record the frequency of dressing replacement from post-operative day 0 to day 7.
0-7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic agent use
Time Frame: 0-7days
Daily consumption of oral analgesics from post-operative day 0 to day 7
0-7days
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.
0-30 days
Incidence of urinary retention
Time Frame: 0-7days
Urinary retention was defined as patients requiring Foley catheterization during the hospital stay.
0-7days
Daily activity
Time Frame: 0-7 days
The number of days the patient takes to go back to work.
0-7 days
Bowel movement
Time Frame: 0-7 days
Duration until first bowel movement after surgery.
0-7 days
Patient satisfaction
Time Frame: Post Operative day 7
Questionnaire will be collected after the surgery.
Post Operative day 7
Length of hospital stay
Time Frame: 0-7 days
Length of hospital stay after the surgery.
0-7 days
Wound healing questionnaire
Time Frame: 0-60 days
Evaluate wound healing at 30 days after operation.
0-60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Shuang Ho Hospital

Investigators

  • Study Director: Tungcheng Chang, MD, PHD, Taipei Medical University Shuang Ho Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

December 14, 2023

First Submitted That Met QC Criteria

December 27, 2023

First Posted (Actual)

December 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N202309013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets used in this study can be obtained from the investigator upon reasonable request.

IPD Sharing Time Frame

data is available as the study is complete and for 12 month period

IPD Sharing Access Criteria

will be shared upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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