Clinical trial NCT05091775: The Efficacy of Asacol (Mesalazine) Suppository on the Treatment of Diarrhea-Induced Acute Fissure
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fissure in Ano
Diarrhea
Keywords: Acute fissure
Diarrhea
Asacol
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups seventy patients aged 18 to 65 years with diarrhea and subsequent acute fissure (with symptoms less than 6 weeks)
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Acute anal fissure after diarrhea. Standard management of acute fissure (Diltiazem Jelly, supportive care, placebo suppository, sitz bath)
timeFrame: 2 weeks
Secondary outcomes:
measure: Acute anal fissure after diarrhea. Intervention group (Asacol suppository, supportive care, placebo suppository, sitz bath)
timeFrame: 3 months
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Leila Ghahramani
state: Fars
Study officials:
References: