NCT06184438

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 14, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 28, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

December 14, 2023

Last Update Submit

May 13, 2025

Conditions

Anal Fistula

Keywords

flavnoidsfistulotomyfistulectomy

Outcome Measures

Primary Outcomes (2)

  • Post-operative pain

    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

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

    0-7 days

Secondary Outcomes (8)

  • Analgesic agent use

    0-7days

  • Incidence of surgical site infection

    0-30 days

  • Incidence of urinary retention

    0-7days

  • Daily activity

    0-7 days

  • Bowel movement

    0-7 days

  • +3 more secondary outcomes

Study Arms (2)

Daflon group

EXPERIMENTAL

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

Drug: Micronized purified flavonoid fraction(Daflon 1000mg)

Placebo group

PLACEBO COMPARATOR

Received placebo after surgery from day 0 to day 7.

Drug: Placebo

Interventions

Micronized purified flavonoid fraction(Daflon 1000mg)DRUG

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

Also known as: diosmin, hesperidin
Daflon group
PlaceboDRUG

Received placebo after surgery.

Also known as: Control group
Placebo group

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who undergo fistulectomy or fistulotomy are included.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University Shuang-Ho Hospital

New Taipei City, 235, Taiwan

Location

MeSH Terms

Conditions

Rectal Fistula

Interventions

DiosminHesperidinControl Groups

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FlavonesFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingFlavanonesGlycosidesCarbohydratesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Tungcheng Chang, MD, PHD

    Taipei Medical University Shuang Ho Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Colorectal Surgery

Study Record Dates

First Submitted

December 14, 2023

First Posted

December 28, 2023

Study Start

December 13, 2023

Primary Completion

January 1, 2025

Study Completion

March 31, 2025

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
data is available as the study is complete and for 12 month period
Access Criteria
will be shared upon request

Locations

TW(1)