Chronic anal fissure Digestive System
Conditions
Interventions
Patients were treated with local incoBoNT/A injection to heal anal fissure with a follow-up of 24 months at the Hospital Nuestra Señora del Prado (Talavera de la Reina, Spain)
A vial of 50 U of BT fr
Xeomin®, Merz Pharmaceuticals GmbH) was diluted in 1.25 ml normal saline, and three syringes were filled with 0.4 ml each (16 U). Patients were placed in the lithotomy position and pretreated with top
Sponsors
Hospital General Nuestra Señora del Prado
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. 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. 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 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 | — |
Countries
Spain
Contacts
Public ContactTeresa Calderón
Outcome results
None listed