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Starting from the observation that acute anal fissure (AAF) in 6-8 weeks can heal spontaneously and that some of the commonly used commercial products in clinical practice would seem to be useful, the rationale of the comparative study is to try to identify, in compliance with the protocol of Helsinki (2013), the most effective short-term treatment for the disappearance of pain in defecation and cessation of bleeding, shortening the duration of the healing process and favoring the patient's rapid return to his / her activity, respect for patient safety.
Starting from the observation that anal fissure in 6-8 weeks can heal spontaneously and that some of the commonly used commercial products in clinical practice would seem to be useful, the rationale of the comparative study is to try to identify, in compliance with the protocol of Helsinki (2013), the most effective short-term treatment for the disappearance of pain in defecation and cessation of bleeding, shortening the duration of the healing process and favoring the patient's rapid return to his / her activity, respect for patient safety.
The comparative study will be conducted by comparing the following products:
Our approach attempts to blend, based on the evidence of the most recent scientific literature, the experience of decades of colonproctologic clinical practice that has a predominantly surgical approach, with the clinical evidence of the Science of Nutrition which has a conservative vision in the treatment of ailments and constipation, a predisposing factor in the pathogenesis of anal fissure, in order to obtain healing without surgery. The control group will receive the traditional basic treatment consisting in the application of lubricated anal dilators of increasing gauge according to predetermined pattern, hygiene and diet. The two groups with which they will be compared for the results will receive, in addition to the foregoing (for controls), or Flavonoids (ProtFlav) or Asian Centella Extract (ProtCent), in the form of local mouth and cream tablets to be applied at the perianal level and possibly in the anal canal with gloved finger, containing the same active principles also administered by mouth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AAF treated with Centella® Complex | Experimental | Centella® Complex 1 cps 60 mg per os |
|
| AAF treated with Proctocella® cream | Experimental | Proctocella® Complex cream to be applied in anal area and anal canal |
|
| AAF treated with Flavonil® cps | Experimental | Flavonil® 1 cps 300 mg per os |
|
| AAF treated with Flavonil® Cream | Experimental | Flavonil® Cream Cream to be applied in anal region and anal canal |
|
| AAF treated with Rectalgan Mousse | Experimental | Rectalgan Mousse cleansing cleanser for anal and perineal region |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Centella | Drug | after meals twice a day for 15 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| time for the disappearance of pain | time for the disappearance of pain in course of treatment | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| time for the disappearance of bleeding | time for the disappearance of bleeding in course of treatment | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General Surgery "Paride Stefanini", University of Rome "La Sapienza" | Rome | RM | 00161 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12135106 | Background | Kim DW, Chi YS, Son KH, Chang HW, Kim JS, Kang SS, Kim HP. Effects of sophoraflavanone G, a prenylated flavonoid from Sophora flavescens, on cyclooxygenase-2 and in vivo inflammatory response. Arch Pharm Res. 2002 Jun;25(3):329-35. doi: 10.1007/BF02976635. | |
| 11922398 | Background | Basile M, Gidaro S, Pacella M, Biffignandi PM, Gidaro GS. Parenteral troxerutin and carbazochrome combination in the treatment of post-hemorrhoidectomy status: a randomized, double-blind, placebo-controlled, phase IV study. Curr Med Res Opin. 2001;17(4):256-61. |
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| ID | Term |
|---|---|
| D005401 | Fissure in Ano |
| D010146 | Pain |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C526146 | Centella asiatica extract |
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| Proctocella |
| Drug |
after hygiene treatment for 4 weeks; |
|
| Flavonil® cps | Drug | after meals twice a day for 15 days |
|
| Flavonil® Cream | Drug | treatment for 4 weeks; . |
|
| Rectalgan Mousse | Drug | for 4 weeks |
|
| 12188628 | Background | Mullen W, McGinn J, Lean ME, MacLean MR, Gardner P, Duthie GG, Yokota T, Crozier A. Ellagitannins, flavonoids, and other phenolics in red raspberries and their contribution to antioxidant capacity and vasorelaxation properties. J Agric Food Chem. 2002 Aug 28;50(18):5191-6. doi: 10.1021/jf020140n. |
| 12025911 | Background | Jantet G. Chronic venous insufficiency: worldwide results of the RELIEF study. Reflux assEssment and quaLity of lIfe improvEment with micronized Flavonoids. Angiology. 2002 May-Jun;53(3):245-56. doi: 10.1177/000331970205300301. |
| 10931020 | Background | Misra MC, Parshad R. Randomized clinical trial of micronized flavonoids in the early control of bleeding from acute internal haemorrhoids. Br J Surg. 2000 Jul;87(7):868-72. doi: 10.1046/j.1365-2168.2000.01448.x. |
| 29844250 | Result | Chiaretti M, Fegatelli DA, Ceccarelli G, Carru GA, Pappalardo G, Chiaretti AI. Comparison of Flavonoids and Centella asiatica for the treatment of chronic anal fissure. A randomized clinical trial. Ann Ital Chir. 2018;89:330-336. |
| D004066 |
| Digestive System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |