The Efficacy of Asacol (Mesalazine) Suppository on the Treatment of Diarrhea-Induced Acute Fissure

The Evaluation of the Efficacy of Asacol (Mesalazine) Suppository on the Treatment of Diarrhea-Induced Acute Fissure in Post-Chemotherapy Cancer Patients - A Randomized Controlled Trial

Anal fissure define as a superficial tearing in mucosa on the anoderm surface distal to dentate line . The most important factor is hard stool passing with trauma to anal mucosa. But, diarrhea diarrhea has been another important etiology that happen after some conditions like gastroenteritis, laxative over use, during chemotherapy, and ulcerative colitis exacerbation . In these conditions, it seems the change of stool PH maybe the main reason of inflammation and ulcer in acute phase.

The treatment of acute is medical management with change in bowel habits and conservative therapy such as local lubricant, local vasodilator, and warm sitz bath to improve blood supply and wound healing.

This research clinical trial is designed to show the effect of Asacol suppository in the management of acute fissure due to diarrhea. The hypothesis of this research clinical trial has been referred to the cause of acute fissure ulcer because of diarrhea.

Study Overview

• Status: Completed
• Conditions: Diarrhea; Fissure in Ano
• Intervention / Treatment: Drug: Asacol is used to treat and prevent mild to moderate acute fissure disease

Detailed Description

The cases with acute anal fissure after diarrhea will included in this research clinical trial. They will be divided in two groups as an interventional group and control by blind randomization allocation. The interventional group will have received Asacol suppository 1 supp every night and Diltiazem jelly (standard management) twice per day. The control group will have received Diltiazem jelly and placebo suppository like interventional group. Both group will have used warm sitz bath with enough hydration for 10 days. Then the patients will have visited by another surgeon after 4 weeks to evaluate the healing of acute anal fissure. Pain will have performed if the patients can tolerate.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of, 7193635899
      • Leila Ghahramani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

For age between 18 and 65 years are the presence of acute anal fissure (with symptoms less than 6 weeks) following chronic diarrhea and subsequent fissure.

Exclusion Criteria:

• Recurrent fissure with skin appendage.
• Long history of constipation.
• Use of immunosuppressive drugs or corticosteroids.
• Inflammatory bowel disease such as Crohn's disease and ulcerative colitis.
• Pregnancy.
• Grade 3 and 4 hemorrhoids.
• Neurological disease.
• Obsessive-compulsive disorder.
• Previous history of anal surgery
• Skin diseases such as eczema and psoriasis.
• Sexually transmitted infections, tuberculosis.
• Mucosal prolapse.
• Anal fistula and pelvic radiotherapy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Standard management of acute fissure(Diltiazem Jelly,supportive care,placebo suppository, sitz bath); Patients in the first group underwent for 14 consecutive days treatment with diltiazem gel 2 times a day, a basin of warm water 2 times a day and drink daily 8-12 a glass of water will be placed with a placebo suppository.	Drug: Asacol is used to treat and prevent mild to moderate acute fissure disease; Comparison of two groups after 2 weeks in fissure wound healing, pain relief, pruritus, burning, bleeding, incontinence. Preliminary results of the study show the rate of fissure improvement 6 weeks after treatment, which is observed by clinical examination. Restoration is defined by complete epithelialization of the fissure site without scarring or residual cracks, and the secondary results will be a reduction in the amount of pain and other symptoms.; Other Names: Mesalazine is used to treat and prevent mild to moderate acute fissure disease
Experimental: Intervention group (Asacol suppository, supportive care, placebo suppository, sitz bath); Patients in the second group or treatment group will be treated with diltiazem gel topically 3 times a day for 14 consecutive days, pelvis of warm water 2 times a day and drink daily 8-12 glasses of water plus Asacol anal suppository (mesalazine) are taken 1 piece every night.	Drug: Asacol is used to treat and prevent mild to moderate acute fissure disease; Comparison of two groups after 2 weeks in fissure wound healing, pain relief, pruritus, burning, bleeding, incontinence. Preliminary results of the study show the rate of fissure improvement 6 weeks after treatment, which is observed by clinical examination. Restoration is defined by complete epithelialization of the fissure site without scarring or residual cracks, and the secondary results will be a reduction in the amount of pain and other symptoms.; Other Names: Mesalazine is used to treat and prevent mild to moderate acute fissure disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute anal fissure after diarrhea. Standard management of acute fissure (Diltiazem Jelly, supportive care, placebo suppository, sitz bath)	bleeding anal fissure. After 2weeks the patients will visit. The score of pain, burning sensation, bleeding and improvement will be recorded in two groups. Score of pain with visual analog scale (VAS) is a tool widely used to measure pain; Scale (0-10) that higher grade means higher pain. Burning sensation (yes, no) and bleeding (yes, no) and improvement (yes, no) will be recorded	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute anal fissure after diarrhea. Intervention group (Asacol suppository, supportive care, placebo suppository, sitz bath)	need surgery or botox injection. Both group including 70 patients that will visit after 2 weeks for evaluating heading acute fissure by history and physical examination. Bleeding(decrease/increase) Pruritus(decrease/increase) Wound healing (according to surgeon evaluation)	3 months

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): August 2, 2020
• Study Completion (Actual): January 10, 2021

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Diarrhea; Acute fissure; Asacol
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Anus Diseases; Diarrhea; Fissure in Ano; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Mesalamine
• Other Study ID Numbers: 98-01-01-21181

Drug and device information, study documents

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