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

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ClinicalTrials.gov Identifier: NCT03355846
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Information provided by (Responsible Party):
Massimo Chiaretti, 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.

Condition or disease Intervention/treatment Phase
Acute Anal Fissure Drug: Centella Drug: Proctocella Drug: Flavonil® cps Drug: Flavonil® Cream Drug: Rectalgan Mousse Phase 4

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  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Pain and Bleeding in Subjects With Acute Anal Fissure: Comparative Evaluation of Three Treatments
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

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



Primary Outcome Measures :
  1. time for the disappearance of pain [ Time Frame: 1 month ]
    time for the disappearance of pain in course of treatment


Secondary Outcome Measures :
  1. time for the disappearance of bleeding [ Time Frame: 1 month ]
    time for the disappearance of bleeding in course of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355846


Contacts
Contact: Massimo Chiaretti, MD PhD MSc +39-06-49970214 massimo.chiaretti@uniroma1.it

Locations
Italy
Department of General Surgery "Paride Stefanini", University of Rome "La Sapienza" Recruiting
Rome, RM, Italy, 00161
Contact: Massimo Chiaretti, MD PhD MSc    +39-06-49970214    massimo.chiaretti@uniroma1.it   
Sponsors and Collaborators
University of Roma La Sapienza

Publications:
Responsible Party: Massimo Chiaretti, Reasercher, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT03355846     History of Changes
Other Study ID Numbers: URomLS-2017-1
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Massimo Chiaretti, University of Roma La Sapienza:
Anal Fissure
local therapy
pain
defecation
bleeding

Additional relevant MeSH terms:
Hemorrhage
Fissure in Ano
Pathologic Processes
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases