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

NCT ID: NCT05091775

Last Updated: 2021-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2021-01-10

Brief Summary

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.

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.

Conditions

Fissure in Ano; Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Asacol is used to treat and prevent mild to moderate acute fissure disease

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Asacol is used to treat and prevent mild to moderate acute fissure disease

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Mesalazine is used to treat and prevent mild to moderate acute fissure disease

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shiraz University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Leila Ghahramani

Clinical Associated professor of colorectal surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Leila Ghahramani

Shiraz, Fars, Iran

Countries

Iran

Other Identifiers

98-01-01-21181

Identifier Type: -

Identifier Source: org_study_id