Clinical trial NCT06184438: Randomized Control Trial of Micronized Purified Flavonoid Fraction for Post Operative Treatment in Anal Fistula Surgery
Official title: Randomized Control Trial of Micronized Purified Flavonoid Fraction for Post Operative Treatment in Anal Fistula Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anal Fistula
Keywords: flavnoids
fistulotomy
fistulectomy
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 106
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-operative pain
timeFrame: 0-7 days
measure: Frequency of dressing replacement
timeFrame: 0-7 days
Secondary outcomes:
measure: Analgesic agent use
timeFrame: 0-7days
measure: Incidence of surgical site infection
timeFrame: 0-30 days
measure: Incidence of urinary retention
timeFrame: 0-7days
measure: Daily activity
timeFrame: 0-7 days
measure: Bowel movement
timeFrame: 0-7 days
measure: Patient satisfaction
timeFrame: Post Operative day 7
measure: Length of hospital stay
timeFrame: 0-7 days
measure: Wound healing questionnaire
timeFrame: 0-60 days
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang-Ho Hospital
Study officials:
affiliation: Taipei Medical University Shuang Ho Hospital
name: Tungcheng Chang, MD, PHD
role: STUDY_DIRECTOR
References: