Botulinum Toxin A in Abdominal Hernia Repair

Phase 4

Recruiting

• Conditions: Massive ventral hernia; Surgery - Surgical techniques; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12624000701527
• Lead Sponsor: Dr Mary Ann Johnson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-04
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• Is greater than and equal to 18 years of ages at enrolment
• Has a large ventral hernia that requires surgical repair as determined by attendance of the Hepatobiliary and Upper Gastrointestinal Surgical Clinic
• Ability to understand study information in English
• Provide a signed and dated informed consent form

Exclusion Criteria

• Emergency procedures
• Prisoners
• Hernia with defect greater than 14cm transversely or more than 50% loss of domain
• Known hypersensitivity to any ingredient in the formulation.
• Participants with myasthenia gravis or Eaton Lambert syndrome.
• Presence of infection at the proposed injection site(s).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hernia recurrence as assessed by the Principal Investigator by physical assessment (height and weight, abdominal examination) and imaging studies (computed tomography (CT)).[ 1 month after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery and 3 years after surgery and 5 years after surgery]