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

NCT ID: NCT03355846

Last Updated: 2018-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2018-05-01

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.

Conditions

Acute Anal Fissure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AAF treated with Centella® Complex

Centella® Complex 1 cps 60 mg per os

Group Type: EXPERIMENTAL

Centella

Intervention Type: DRUG

after meals twice a day for 15 days

AAF treated with Proctocella® cream

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

Group Type: EXPERIMENTAL

Proctocella

Intervention Type: DRUG

after hygiene treatment for 4 weeks;

AAF treated with Flavonil® cps

Flavonil® 1 cps 300 mg per os

Group Type: EXPERIMENTAL

Flavonil® cps

Intervention Type: DRUG

after meals twice a day for 15 days

AAF treated with Flavonil® Cream

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

Group Type: EXPERIMENTAL

Flavonil® Cream

Intervention Type: DRUG

treatment for 4 weeks;

.

AAF treated with Rectalgan Mousse

Rectalgan Mousse cleansing cleanser for anal and perineal region

Group Type: EXPERIMENTAL

Rectalgan Mousse

Intervention Type: DRUG

for 4 weeks

Interventions

Centella

after meals twice a day for 15 days

Intervention Type: DRUG

Proctocella

after hygiene treatment for 4 weeks;

Intervention Type: DRUG

Flavonil® cps

after meals twice a day for 15 days

Intervention Type: DRUG

Flavonil® Cream

treatment for 4 weeks;

.

Intervention Type: DRUG

Rectalgan Mousse

for 4 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Massimo Chiaretti

Reasercher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of General Surgery "Paride Stefanini", University of Rome "La Sapienza"

Rome, RM, Italy

Countries

Italy

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: RESULT

PMID: 29844250 (View on PubMed)

Other Identifiers

URomLS-2017-1

Identifier Type: -

Identifier Source: org_study_id