None listed
Conditions
Brief summary
Large ventral hernias are a source of significant morbidity and pose a considerable surgical challenge. A hernia is abdominal wall muscular defect, allowing protrusion of abdominal contents under the skin. Surgical repair brings the edges of the abdominal wall opening (muscle edges) together. BTA prevents the muscles from contracting (approx 3 months) and thus reduces the lateral pulling 'force' on the surgical repair of the hernia. The study aims to perform a double- blinded randomised placebo-controlled trial to evaluate the effectiveness of BTA as an adjunct to surgical hernia repair of large ventral hernias. Participants will be randomised into two groups: one group will receive BTA injections, the other normal saline injections, into abdominal musculature. All participants will then undergo a surgical hernia repair 4 to 6 weeks after the injections. 84 participants will be recruited to each group (total: 168 participants). Our hypothesis is that BTA can improve the success of hernia repair by better intra-operative closure, better post-operative recovery , reduced recurrence of a hernia and overall reduced health expenditure.
Interventions
Botulinum toxin type A - 200 units in 200mL of saline for injection into abdominal wall musculature once, at 4-6 weeks before surgery. Adherence is considered as positive when participant has received all injections.
The injection points will be three evenly spaced spots along the front side of the body between the bottom edge of the ribs and the top of the hip bone on each side. A total of six injections will be administered by the investigator general surgeon.
Completion of the intervention w
Botulinum toxin type A - 200 units in 200mL of saline for injection into abdominal wall musculature once, at 4-6 weeks before surgery. Adherence is considered as positive when participant has received all injections. The injection points will be three evenly spaced spots along the front side of the body between the bottom edge of the ribs and the top of the hip bone on each side. A total of six injections will be administered by the investigator general surgeon. Completion of the intervention will be noted on the participant case report form.
Sponsors
Dr Mary Ann Johnson
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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).
Outcome results
None listed