The treatment of chronic anal fissures with fissure excision and Botulinum Toxin Type A injection

Open comparative randomized clinical study of the influence of Botulinum Toxin Type A injection vs. anal dilatation with inflatable balloon in patients after chronic anal fissure excision on the frequency and duration of following anal sphincter insufficiency.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN97413456

Enrollment

Registered

2018-11-22

Start date

2017-10-17

Completion date

Unknown

Last updated

2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic anal fissure Digestive System Chronic anal fissure

Interventions

Participants were randomised using the envelope method into either the intervention or control group. Before surgery, all participants will have their pain, anal incontinence and anorectal manometry a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years old 2. Chronic anal fissure

Exclusion criteria

Exclusion criteria: 1. Inflammatory disease of the colon 2. Pectenosis 3. Previous surgical interventions of the anal canal 4. II-IV grade internal haemorrhoids 5. Rectal fistula 6. Severe somatic diseases at the decompensation stage 7. Pregnancy 8. Lactation 9. Intolerance or hypersensitivity to Botulinum toxin 10. Myasthenia gravis and myasthenia-like syndromes

Design outcomes

Primary

Measure	Time frame
Frequency of anal sphincter insufficiency, assessed using the Wexner score 60 days after surgery.	—

Secondary

Measure	Time frame
1. Frequency and structure of complications, assessed through clinical examinations at 7, 30 and 60 days after surgery 2. Pain syndrome assessed using visual analogue scale (VAS) before surgery and everyday until 60 days after surgery 3. Anorectal manometry parameters, assessed before surgery and 7 and 60 days after surgery, including: 3.1. Mean resting anal pressure 3.2. Maximum resting anal pressure 3.3. Mean squeezing anal pressure 3.4. Maximum squeezing anal pressure 4. Duration of temporary disability: 4.1. First day that patients return to work after surgery 4.2. 36-item Short Form Health Survey (SF-36) assessed the day after surgery, along with 30 and 60 days after 5. Frequency of post-operative wound epithelialization, assessed through a clinical examination of whether the wound has healed 60 days after surgery 6. Relapse rate, determined by the number of patients that return to the clinic with complaints of pain during the study period	—

Measure

Time frame

1. Frequency and structure of complications, assessed through clinical examinations at 7, 30 and 60 days after surgery 2. Pain syndrome assessed using visual analogue scale (VAS) before surgery and everyday until 60 days after surgery 3. Anorectal manometry parameters, assessed before surgery and 7 and 60 days after surgery, including: 3.1. Mean resting anal pressure 3.2. Maximum resting anal pressure 3.3. Mean squeezing anal pressure 3.4. Maximum squeezing anal pressure 4. Duration of temporary disability: 4.1. First day that patients return to work after surgery 4.2. 36-item Short Form Health Survey (SF-36) assessed the day after surgery, along with 30 and 60 days after 5. Frequency of post-operative wound epithelialization, assessed through a clinical examination of whether the wound has healed 60 days after surgery 6. Relapse rate, determined by the number of patients that return to the clinic with complaints of pain during the study period

—

Countries

Russian Federation

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026