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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anal Fistula

Intervention / Treatment
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* Drug: Micronized purified flavonoid fraction(Daflon 1000mg)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Received MPFF(Daflon 1000mg BID) after surgery. Received placebo after surgery.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daflon group<br>Received Micronized purified flavonoid fraction(Daflon 1000mg) BID after surgery from day 0 to day 7. | Drug: Micronized purified flavonoid fraction(Daflon 1000mg)<br>* Received Micronized purified flavonoid fraction(Daflon 1000mg) BID after surgery from day to day 7<br>* Other names: hesperidin;|
| Placebo Comparator: Placebo group<br>Received placebo after surgery from day 0 to day 7. | Drug: Placebo<br>* Received placebo after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flavnoids, fistulotomy, fistulectomy