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

Phase 4

Completed

• Conditions: Acute Anal Fissure
• Interventions: Drug: Flavonil® Cream; Drug: Proctocella; Drug: Centella; Drug: Flavonil® cps; Drug: Rectalgan Mousse

• Registration Number: NCT03355846
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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

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.

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-22
• Study First Submitted QC: 2017-11-22
• Study First Posted: 2017-11-28
• Study Start: 2018-05-01
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-01
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Subjects With Acute Anal Fissure
• Collaborative patients able to understand and want;

Exclusion Criteria

• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AAF treated with Flavonil® Cream	Flavonil® Cream	Flavonil® Cream Cream to be applied in anal region and anal canal
AAF treated with Proctocella® cream	Proctocella	Proctocella® Complex cream to be applied in anal area and anal canal
AAF treated with Centella® Complex	Centella	Centella® Complex 1 cps 60 mg per os
AAF treated with Flavonil® cps	Flavonil® cps	Flavonil® 1 cps 300 mg per os
AAF treated with Rectalgan Mousse	Rectalgan Mousse	Rectalgan Mousse cleansing cleanser for anal and perineal region

Primary Outcome Measures

Name	Time	Method
time for the disappearance of pain	1 month	time for the disappearance of pain in course of treatment

Secondary Outcome Measures

Name	Time	Method
time for the disappearance of bleeding	1 month	time for the disappearance of bleeding in course of treatment

Trial Locations

Locations (1)

Department of General Surgery "Paride Stefanini", University of Rome "La Sapienza"; 🇮🇹 Rome, RM, Italy