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

University of Roma La Sapienza

Status and phase: Completed; Phase 4

Conditions: Acute Anal Fissure

Treatments: Drug: Centella; Drug: Flavonil® Cream; Drug: Proctocella; Drug: Flavonil® cps; Drug: Rectalgan Mousse

Study type: Interventional

Funder types: Other

Identifiers

NCT03355846

URomLS-2017-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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99 participants in 5 patient groups

AAF treated with Centella® Complex

Experimental group

Description:

Centella® Complex 1 cps 60 mg per os

Treatment:

Drug: Centella

AAF treated with Proctocella® cream

Experimental group

Description:

Proctocella® Complex cream to be applied in anal area and anal canal

Treatment:

Drug: Proctocella

AAF treated with Flavonil® cps

Experimental group

Description:

Flavonil® 1 cps 300 mg per os

Treatment:

Drug: Flavonil® cps

AAF treated with Flavonil® Cream

Experimental group

Description:

Flavonil® Cream Cream to be applied in anal region and anal canal

Treatment:

Drug: Flavonil® Cream

AAF treated with Rectalgan Mousse

Experimental group

Description:

Rectalgan Mousse cleansing cleanser for anal and perineal region

Treatment:

Drug: Rectalgan Mousse