The Efficacy of Botulinum Toxin Alone Versus Combined Botulinum Toxin and Topical Diltiazem in Chronic Anal Fissure

NCT ID: NCT05797220

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 217 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-04
• Study Completion Date: 2024-08-30

Brief Summary

Anal fissure (AF) is a painful tear extending from the anal canal to the dentate line. Although the exact pathophysiology is not known, an increase in anal tonus, decreased ano-dermal blood flow and local ischemia are possible mechanisms. The most effective treatment modality in chronic AF is lateral internal sphincterotomy however, incontinence rates are still reported as high as 8-30%. Topical diltiazem and botulinum toxin (BT) injection are good alternatives to surgery with lack of persistent side effects, easy applicability, and reproducibility, however, recurrence rates were reported up to 50% for each. A combination of BT with topical diltiazem may provide better results in terms of healing and recurrence. In this retrospective analysis a comparison of BT injection alone and BT injection combined with topical diltiazem treatment was performed.

Conditions

Anal Fissure Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Botulinum toxin group

The procedures were performed at outpatient clinic without anesthesia. Lyophilized 100 IU BT Type-A (BOTOX, Alergan, CA, USA) was applied after diluted with 1 cc saline. A 26-G injector was used to inject 25 unit toxin in every 4 quadrants, to the alignment of clock 12, 3, 6, and 9 to internal anal sphincters.

Botulinum Toxin Type A Injection [Botox]

Intervention Type: DRUG

Botulinum toxin plus topical diltiazem group

The procedures were performed at outpatient clinic without anesthesia. Lyophilized 100 IU BT Type-A (BOTOX, Alergan, CA, USA) was applied after diluted with 1 cc saline. A 26-G injector was used to inject 25 unit toxin in every 4 quadrants, to the alignment of clock 12, 3, 6, and 9 to internal anal sphincters. After BT injection, topical 2% diltiazem gel was prescribed, applied 2 times per day for 10 days (2 doses of 1 gr each per day). No selection criteria were used when recommending this treatment; it was randomly suggested to some for a while during the cohort since the surgeon believed it might enhance the efficacy of BT.

Botulinum Toxin Type A Injection [Botox] + Diltiazem Hydrochloride 20 Mg/G Rectal Gel

Intervention Type: DRUG

Interventions

Botulinum Toxin Type A Injection [Botox]

Intervention Type: DRUG

Botulinum Toxin Type A Injection [Botox] + Diltiazem Hydrochloride 20 Mg/G Rectal Gel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with complaints longer than 8 weeks (chronic anal fissure)
• Patients who completed at least 24 months of follow-up (3rd day, 10th day, 1st-month, and 2nd-month face-to-face clinic visits and 6, 12, and 24 months phone calls)
• Patients who received conservative treatments including topical diltiazem and nitrites

Exclusion Criteria

• Patients with previous anal surgery (lateral internal sphincterotomy, hemorrhoidectomy, anal fistula)
• Patients with inflammatory bowel diseases
• Patients with accompanying anorectal disease (hemorrhoids, anal fistula, abscess)
• Patients who underwent botulinum toxin injection within 1 year before recruitment
• Patients with anterior, lateral, or multiple fissures
• Comorbidities (AIDS, sexually transmitted disease, tuberculosis, leukemia)
• Pregnancy
• Prescription of calcium canal blockers or nitrites
• Hypersensitivity to diltiazem or botulinum toxin
• Patients without anal pain

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cigdem Arslan

Consultant Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naciye Cigdem Arslan, MD

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

Istanbul Medipol University

Istanbul, Other (Non U.s.), Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-10840098-772.02-786

Identifier Type: -

Identifier Source: org_study_id