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

Acute Anal Fissure Clinical Trial

— PBSAAF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03355846
• Other study ID #: URomLS-2017-1
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2018
• Est. completion date: May 1, 2018

Study information

• Verified date: November 2017
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Subjects With Acute Anal Fissure

• Collaborative patients able to understand and want;

Exclusion Criteria:

• Pregnancy

Related Conditions & MeSH terms

• Acute Anal Fissure
• Fissure in Ano
• Hemorrhage

Intervention

Drug:
• Centella
after meals twice a day for 15 days
• Proctocella
after hygiene treatment for 4 weeks;
• Flavonil® cps
after meals twice a day for 15 days
• Flavonil® Cream
treatment for 4 weeks;
• Rectalgan Mousse
for 4 weeks

Locations

Country	Name	City	State
Italy	Department of General Surgery "Paride Stefanini", University of Rome "La Sapienza"	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View Citation

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 May 28;7. pii: S0003469X18028737. [Ep — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time for the disappearance of pain	time for the disappearance of pain in course of treatment	1 month
Secondary	time for the disappearance of bleeding	time for the disappearance of bleeding in course of treatment	1 month