Is neuromodulation with botulinum toxin type A an alternative treatment for chronic anal fissure?

Not Applicable

Completed

• Conditions: Chronic anal fissure; Digestive System

• Registration Number: ISRCTN90354265
• Lead Sponsor: Hospital General Nuestra Señora del Prado

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-06-01
• Study Start: 2024-02-16
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1. Aged over 18 years
2. Clinical anal fissure diagnosis for over 2 months that had not responded to previous treatments consisting of dietary and behavioral modifications, analgesics, and local treatment with calcium channel blocker (diltiazem 2%) or nitrates (trinitrate glyceryl 0.4%)

Exclusion Criteria

1. Non-idiopathic anal fissures
2. Previously untreated patients
3. BT contraindication such as miastenia gravis, Eaton-Lambert syndrome, pregnancy, and acetylcholine deficiency

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Healing rate at 2 years. Healing was defined as scarred AF and without symptoms; improvement was considered when the fissure persisted without symptoms; failure presented persistent fissure and symptoms. Patients who required a surgical approach were considered as a failure. Healing/improvement was assessed at 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years post-injection.

Secondary Outcome Measures

Name	Time	Method
1. Anal manometry assessment of the internal anal sphincter (IAS) to measure anal resting pressure, voluntary squeeze pressure and pressure during the Valsalva maneuver. IAS pressures were measured using the THD® Anopress system (mmHg) at baseline and at 1 and 3 months post-injection.<br>2. Pain perception was measured using a pain visual analog scale (VAS) (scoring between 0 [no pain] and 10 [severe pain]) at baseline, 1 month, 3 months, 6 months, 1 year, and 2 years post-injection. Pain perception was also measured at 1 week.<br>3. Incontinence was measured using the Wexner score (scoring between 0 [no incontinence] and 20 [total incontinence]) at baseline, 1 month, 3 months, 6 months, 1 year, and 2 years post-injection<br>4. Quality of life was assessed with the SF-36 questionnaire (scoring between 0 [worst health status] and 100 [best health status]) at baseline and 3 months post-injection