Pain and Bleeding in Subjects With Acute Anal Fissure: Comparative Evaluation of Three Treatments

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Centella® Complex 1 cps 60 mg per os after meals twice a day for 15 days; Proctocella® Complex cream to be applied in anal area and anal canal after hygiene treatment for 4 weeks; Flavonil® 1 cps 300 mg per os after meals twice a day for 15 days; Flavonil® Cream Cream to be applied in anal region and anal canal after hygiene treatment for 4 weeks; Rectalgan Mousse cleansing cleanser for anal and perineal region for 4 weeks. 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.

Official Title
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Pain and Bleeding in Subjects With Acute Anal Fissure: Comparative Evaluation of Three Treatments

Conditions
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Acute Anal Fissure

Intervention / Treatment
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* Drug: Centella
* Drug: Proctocella
* Drug: Flavonil® cps
* Drug: Flavonil® Cream
* Drug: Rectalgan Mousse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects With Acute Anal Fissure Collaborative patients able to understand and want; Exclusion Criteria: Pregnancy

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AAF treated with Centella® Complex<br>Centella® Complex 1 cps 60 mg per os | Drug: Centella<br>* after meals twice a day for 15 days<br>|
| Experimental: AAF treated with Proctocella® cream<br>Proctocella® Complex cream to be applied in anal area and anal canal | Drug: Proctocella<br>* after hygiene treatment for 4 weeks;<br>|
| Experimental: AAF treated with Flavonil® cps<br>Flavonil® 1 cps 300 mg per os | Drug: Flavonil® cps<br>* after meals twice a day for 15 days<br>|
| Experimental: AAF treated with Flavonil® Cream<br>Flavonil® Cream Cream to be applied in anal region and anal canal | Drug: Flavonil® Cream<br>* treatment for 4 weeks; .<br>|
| Experimental: AAF treated with Rectalgan Mousse<br>Rectalgan Mousse cleansing cleanser for anal and perineal region | Drug: Rectalgan Mousse<br>* for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time for the disappearance of pain | time for the disappearance of pain in course of treatment | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time for the disappearance of bleeding | time for the disappearance of bleeding in course of treatment | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anal Fissure, local therapy, pain, defecation, bleeding