Clinical trial NCT03355846: Pain and Bleeding in Subjects With Acute Anal Fissure: Comparative Evaluation of Three Treatments
Official title: Pain and Bleeding in Subjects With Acute Anal Fissure: Comparative Evaluation of Three Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Anal Fissure
Keywords: Anal Fissure
local therapy
pain
defecation
bleeding
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: time for the disappearance of pain
timeFrame: 1 month
Secondary outcomes:
measure: time for the disappearance of bleeding
timeFrame: 1 month
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Department of General Surgery "Paride Stefanini", University of Rome "La Sapienza"
state: RM
Study officials:
References:
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