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Completed

NCT Number: NCT05797220

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

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.

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Key information

Conditions

Anal Fissure Chronic Anus Diseases Digestive System Diseases Fissure in Ano Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medipol University

Istanbul, Other (Non U.s.), 34196, Turkey (Türkiye)

Who can participate

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

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

Treatment and study plan

Botulinum Toxin Type A Injection [Botox]

Drug

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

Drug

Primary outcomes

  1. Fissure healing at 1 month

    Time frame: 1 month

    Evaluation of complete epithelization of the fissure by the principal investigator by rectal examination

  2. Days to pain-free defecation

    Time frame: 1 month

    Patient reported time until pain-free defecation. This will be evaluated on 3rd day, 10th day and 1-month outpatient visits.

Secondary outcomes

  1. Complete healing at 48 months

    Time frame: 48 months

    Any recurrent symptoms evaluated by the surgeon within 2 months in the outpatient clinic and reported by the patient at phone call follow-up at 6 months, 12 months, 24 months, and 48 months.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Retrospective Analysis on the Efficacy of Botulinum Toxin Alone Versus Combined Botulinum Toxin and Topical Diltiazem in Chronic Anal Fissure: Short and Long-term Outcomes From a Single Center

Important dates

Study start
2016
Primary completion
2020
Study completion
2024
First posted
Apr 4, 2023
Registry last updated
Sep 4, 2024

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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