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Botulinum toxin injection vs Surgery for chronic anal fissure

Comparative Study of Botulinum Toxin Injection and Lateral Internal Sphincterotomy in the treatment of Chronic Anal Fissure

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023878
Enrollment
60
Registered
2020-03-11
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: K601- Chronic anal fissure

Interventions

Intervention1: Botulinum Toxin Injection: 20 IU injection into anal sphincter. Single dose Control Intervention1: Lateral Internal Sphincterotomy: Surgical procedure for chronic anal fissure

Sponsors

Institute of General Surgery
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Chronic anal fissure

Exclusion criteria

Exclusion criteria: Acute fissure in ano,hemorrhoids, fistula in ano, allergic reaction to Botulinum toxin, diabetics, hypertensives

Design outcomes

Primary

MeasureTime frame
Healing of fissure seen by formation of stable scarTimepoint: 6 weeks 1 month 3 months

Secondary

MeasureTime frame
Measurement of incontinence by calculating Wexner scaleTimepoint: 6 weeks 3 months

Countries

India

Contacts

Public ContactS Maniselvi

Madras Medical College

drmaniselvi@yahoo.com

Outcome results

None listed

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