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

NCT05797220 | Completed FDA Drug

• 1 other identifier: E-10840098-772.02-786
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 1

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

Keywords

botulinum toxin, anal fissure, diltiazem

Outcome Measures

Primary Outcomes (2)

• Fissure healing at 1 month

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

  1 month

• Days to pain-free defecation

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

  1 month

Secondary Outcomes (1)

• Complete healing at 48 months

  48 months

Study Arms (2)

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.

Drug: Botulinum Toxin Type A Injection [Botox]

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.

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

Interventions

Botulinum Toxin Type A Injection [Botox] DRUG

Botulinum toxin group

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

Botulinum toxin plus topical diltiazem group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female and males older than 18 years old

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

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

Location

MeSH Terms

Conditions

Fissure in Ano

Interventions

Botulinum Toxins, Type A; Diltiazem

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Naciye Cigdem Arslan, MD

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Surgeon

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: April 4, 2023
• Study Start: November 4, 2016
• Primary Completion: June 30, 2020
• Study Completion: August 30, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-08

Locations

TU (1)