Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daflon group | Experimental | Received Micronized purified flavonoid fraction(Daflon 1000mg) BID after surgery from day 0 to day 7. |
|
| Placebo group | Placebo Comparator | Received placebo after surgery from day 0 to day 7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micronized purified flavonoid fraction(Daflon 1000mg) | Drug | Received Micronized purified flavonoid fraction(Daflon 1000mg) BID after surgery from day to day 7 |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tungcheng Chang, MD, PHD | Taipei Medical University Shuang Ho Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Shuang-Ho Hospital | New Taipei City | 235 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41776089 | Derived | Tsai YW, Kiu KT, Chang TC. Efficacy of micronized purified flavonoid fraction in reducing pain after anal fistula surgery: a randomized controlled trial. Tech Coloproctol. 2026 Mar 3;30(1):36. doi: 10.1007/s10151-026-03298-5. |
Not provided
Not provided
The datasets used in this study can be obtained from the investigator upon reasonable request.
data is available as the study is complete and for 12 month period
will be shared upon request
Not provided
Not provided
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:
Not provided
Not provided
Not provided
|
| Placebo | Drug | Received placebo after surgery. |
|
|
| 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 |
| ID | Term |
|---|---|
| D012003 | Rectal Fistula |
| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004145 | Diosmin |
| D006569 | Hesperidin |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D047309 | Flavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D044950 | Flavanones |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
Not provided
Not provided