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

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.

Study Overview

• Status: Completed
• Conditions: Acute Anal Fissure
• Intervention / Treatment: Drug: Centella; Drug: Proctocella; Drug: Flavonil® cps; Drug: Flavonil® Cream; Drug: Rectalgan Mousse

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 Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • RM
    • Rome, RM, Italy, 00161
      • Department of General Surgery "Paride Stefanini", University of Rome "La Sapienza"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 11, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: pain; bleeding; defecation; Anal Fissure; local therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Anus Diseases; Hemorrhage; Fissure in Ano
• Other Study ID Numbers: URomLS-2017-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No