RecruitingPhase 4ACTRN12624000701527

Botulinum Toxin A in Abdominal Hernia Repair

The efficacy of Botulinum Toxin A (BTA) as an Adjunct to Surgical Repair of Large Ventral Hernia in Adults, A Randomised Controlled Trial


Sponsor

Dr Mary Ann Johnson

Enrollment

168 participants

Start Date

Jun 13, 2023

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Large hernias in the abdominal wall — where internal organs push through a weakness or opening in the muscle — can be difficult to repair surgically because the abdominal muscles pull outward with considerable force, putting strain on the repair site. Botulinum Toxin A (BTA, commonly known as Botox) can temporarily relax these muscles for about three months, potentially making surgery easier and reducing the chance of the hernia coming back. This double-blinded randomised trial will compare outcomes for 168 patients who receive either BTA injections or saline (placebo) injections into their abdominal muscles 4–6 weeks before hernia repair surgery. Researchers will assess how well the hernia closes during surgery, recovery speed, recurrence rates, and healthcare costs. You may be eligible if you are 18 or older and have a large ventral hernia that requires surgical repair, as assessed at the relevant surgical clinic. People with myasthenia gravis, Eaton Lambert syndrome, a hernia defect greater than 14 cm wide, or an infection at the injection site are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(4)

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

VIC, Australia

Epworth Eastern Hospital - Box Hill

VIC, Australia

Box Hill Hospital - Box Hill

VIC, Australia

Royal Melbourne Hospital - Royal Park campus - Parkville

VIC, Australia

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ACTRN12624000701527