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NCT Number: NCT05091775

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

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.

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Key information

Conditions

Fissure in Ano Anus Diseases Diarrhea Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Leila Ghahramani

Shiraz, Fars, 7193635899, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

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

Primary outcomes

  1. Acute anal fissure after diarrhea. Standard management of acute fissure (Diltiazem Jelly, supportive care, placebo suppository, sitz bath)

    Time frame: 2 weeks

    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

Secondary outcomes

  1. Acute anal fissure after diarrhea. Intervention group (Asacol suppository, supportive care, placebo suppository, sitz bath)

    Time frame: 3 months

    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)

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Oct 25, 2021
Registry last updated
Oct 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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