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

Anal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06184438
• Other study ID #: N202309013
• Status: Recruiting
• Phase: Phase 4
• Start date: December 13, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: April 2024
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: Tungcheng Chang, MD, PHD
• Phone: +886-2-22490088
• Email: rotring810[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Drug:
• Micronized purified flavonoid fraction(Daflon 1000mg)
Received Micronized purified flavonoid fraction(Daflon 1000mg) BID after surgery from day to day 7
• Placebo
Received placebo after surgery.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Shuang-Ho Hospital	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain	Record the maximum pain score(visual analog scale, 0-10) from post-operative day 0 to day 7.	0-7 days
Primary	Frequency of dressing replacement	Record the frequency of dressing replacement from post-operative day 0 to day 7.	0-7 days
Secondary	Analgesic agent use	Daily consumption of oral analgesics from post-operative day 0 to day 7	0-7days
Secondary	Incidence of surgical site infection	Surgical site infection was defined as hospital admission for infection management or need for surgical intervention to manage the wound.	0-30 days
Secondary	Incidence of urinary retention	Urinary retention was defined as patients requiring Foley catheterization during the hospital stay.	0-7days
Secondary	Daily activity	The number of days the patient takes to go back to work.	0-7 days
Secondary	Bowel movement	Duration until first bowel movement after surgery.	0-7 days
Secondary	Patient satisfaction	Questionnaire will be collected after the surgery.	Post Operative day 7
Secondary	Length of hospital stay	Length of hospital stay after the surgery.	0-7 days
Secondary	Wound healing questionnaire	Evaluate wound healing at 30 days after operation.	0-60 days