The Efficacy of Botulinum Toxin A as an Adjunct to Surgical Hernia repair on Large Ventral Hernia, A Randomised Controlled Trial.

Abdominal hernias involve the protrusion of abdominal contents, such as bowel or fat, through an opening or weakness in the abdominal wall. They are common and can be caused by previous surgery, trauma or can be present from birth. Large abdominal hernias can become painful and debilitating, preventing people from walking or completing normal activities. This lack of mobility can lead to weight gain, diabetes, skin infections and other problems. Many people with large hernias feel shame about their appearance and struggle to leave their home. Abdominal hernias can be repaired with surgery but, in the case of large hernias, the recurrence rate is up to 25% due to a variety of factors. The cosmetic injectable Botox has emerged as a promising adjunct in the repair of large abdominal hernias. Botox works by paralysing targeted abdominal muscles to minimise the pulling forces on the hernia repair. We think that this will allow for improved surgical recovery, a reduction on postoperative pain and a reduction in the rate of hernia recurrence.

Aim:

  • To improve surgical recovery
  • To reduce post surgical pain
  • To reduce rate of hernia recurrence
 
 

Status: Currently recruiting

Site: St Vincent’s Public Hospital Melbourne, St Vincent’s Private Hospital, Epworth Health Care

Ethics: Approved

Principal Investigator: Dr Mary Ann Johnson, Dr Lynn Chong

 

Eligibility

Inclusion

  • Adults ≥18 years of age

  • Has a large ventral hernia that requires surgical repair as determined by the treating surgeon

  • Ability to understand study information in English

  • Provide a signed and dated informed consent form

  • Has Medicare

Exclusion

  • Emergency procedures

  • Prisoners

  • Hernia with defect greater than 14cm transversely or more than 50% loss of domain (giant hernia)

  • 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 Measures

  • Pain score - Visual Analog Score (VAS)

  • Opioid use

  • Hernia Questionnaire - HerQles

  • Quality of Life Questionnaire

  • Patient-reported outcomes for interventional trials assessing ventral hernia repair

Funded by