Effect of Additional Topical Diltiazem on Botulinum Toxin Injection for Chronic Anal Fissure

Anal Fissure Chronic Clinical Trial

Official title:

Effect of Additional Topical Diltiazem on Botulinum Toxin Injection for Chronic Anal Fissure: Retrospective Analysis of 217 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05797220
• Other study ID #: E-10840098-772.02-786
• Status: Completed
• Start date: November 4, 2016
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2022
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with complaints longer than 8 weeks (chronic anal fissure)
• Patients who completed 24 months of follow-up (3rd day, 10th day, 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

Related Conditions & MeSH terms

• Anal Fissure Chronic
• Fissure in Ano

Intervention

Drug:
• Botulinum Toxin Type A Injection [Botox]

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

Locations

Country	Name	City	State
Turkey	Medipol Bahcelievler Hospital	Istanbul	Other (Non U.s.)

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fissure healing at 1 month	Evaluation of complete epithelization of the fissure by the principal investigator by rectal examination	1 month
Secondary	Recurrence at 24 months	Any recurrent symptoms reported by the patient at phone call follow-up	24 months