Partial Lateral Internal Sphincterotomy Versus Combined Botulinum Toxin A Injection and Topical Application of Diltiazem in Treatment of Chronic Anal Fissure

Phase 2

Completed

• Conditions: Chronic Anal Fissure.; Chronic Anal Fissure

• Registration Number: IRCT2013042812294N3
• Lead Sponsor: Vice chancellor for research, Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

diagnosis of chronic anal fissure on physical examination (based on having indurations at the edges and having at least two criteria of these three including skin tag; hypertrophied anal papillae and exposed internal sphincter muscle fiber) by an experienced
colorectal surgeon associated with painful defecation for at least 2 month; age between 18 and 100 years old.
Exclusion criteria:
acute anal fissure (experiencing symptoms less than two months); pregnancy; secondary anal fissure; hypersensitivity to DTZ or BTA; cardiovascular disease; previous history of anal surgery; atypical fissure and chronic headache.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wound healing. Timepoint: one week, 1,2,6 and 12 months postoperatively. Method of measurement: Complete Wound Healing (macroscopic epithelialization).

Secondary Outcome Measures

Name	Time	Method
Complications. Timepoint: , one week, 1,2,6,12 months postoperatively. Method of measurement: physical examination and history taking, VAS.;Induration, hypertrophied papilla, exposing internal anal sphincter,skin tag. Timepoint: before and after surgery. Method of measurement: physical examination.;Pain. Timepoint: before treatment, 1 week, 1,2,6 and 12 months postoperatively. Method of measurement: visual analog scale.;Chronicity of fissure. Timepoint: before treatment. Method of measurement: history taking.;Fissure localization. Timepoint: before treatment. Method of measurement: physical examination.;Bleeding. Timepoint: before treatment, 1 week, 1,2,6 and 12 months postoperatively. Method of measurement: history taking.;Pain at night. Timepoint: before treatment, 1 week, 1,2,6 and 12 months postoperatively. Method of measurement: history taking.;Recurrence. Timepoint: 1 ,2,6 and 12 month postoperatively. Method of measurement: history taking and physical examination.