The aim of this study is to evaluate the effect of micronized purified flavonoid fraction on postoperative symptoms after surgery of anorectal fistulas.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
106
Received Micronized purified flavonoid fraction(Daflon 1000mg) BID after surgery from day to day 7
Received placebo after surgery.
Taipei Medical University Shuang-Ho Hospital
New Taipei City, Taiwan
Post-operative pain
Record the maximum pain score(visual analog scale, 0-10) from post-operative day 0 to day 7.
Time frame: 0-7 days
Frequency of dressing replacement
Record the frequency of dressing replacement from post-operative day 0 to day 7.
Time frame: 0-7 days
Analgesic agent use
Daily consumption of oral analgesics from post-operative day 0 to day 7
Time frame: 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.
Time frame: 0-30 days
Incidence of urinary retention
Urinary retention was defined as patients requiring Foley catheterization during the hospital stay.
Time frame: 0-7days
Daily activity
The number of days the patient takes to go back to work.
Time frame: 0-7 days
Bowel movement
Duration until first bowel movement after surgery.
Time frame: 0-7 days
Patient satisfaction
Questionnaire will be collected after the surgery.
Time frame: Post Operative day 7
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Length of hospital stay
Length of hospital stay after the surgery.
Time frame: 0-7 days
Wound healing questionnaire
Evaluate wound healing at 30 days after operation.
Time frame: 0-60 days