Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000701527
Ethics application status
Approved
Date submitted
4/04/2024
Date registered
4/06/2024
Date last updated
4/06/2024
Date data sharing statement initially provided
4/06/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Botulinum Toxin A in Abdominal Hernia Repair
Scientific title
The efficacy of Botulinum Toxin A (BTA) as an Adjunct
to Surgical Repair of Large Ventral Hernia in Adults, A Randomised Controlled Trial
Secondary ID [1] 296858 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Massive ventral hernia
 328246 0
Condition category
Condition code
Surgery 325294 325294 0 0
Surgical techniques
Oral and Gastrointestinal 330528 330528 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Musculoskeletal 330529 330529 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 324893 0
Treatment: Drugs
Comparator / control treatment
Normal saline - 200 units for injection into abdominal wall musculature once, at 4-6 weeks before surgery. Adherence is considered as positive when participant has received all injections.
Control group
Placebo

Outcomes
Primary outcome [1] 337893 0
Hernia recurrence as assessed by the Principal Investigator by physical assessment (height and weight, abdominal examination) and imaging studies (computed tomography (CT)).
Timepoint [1] 337893 0
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
Secondary outcome [1] 433611 0
Pain as assessed by the 10-point pain Visual Analog Scale
Timepoint [1] 433611 0
First five days post-operatively, and at 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
Secondary outcome [2] 433612 0
Effect of hernia on quality of life will be assessed using the HerQles: Hernia related Quality of Life Survey.
Timepoint [2] 433612 0
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
Secondary outcome [3] 435616 0
Effect of hernia on quality of life will be assessed using the SF-36: Short form 36 item survey.
Timepoint [3] 435616 0
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
Secondary outcome [4] 435617 0
Effect of hernia on quality of life will be assessed using the PRO-VHR: Patient-reported outcomes for interventional trials assessing ventral hernia repair
Timepoint [4] 435617 0
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

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation plan limited to study coordination team and pharmacy only. Central randomisation by computer is allocated to pharmacy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/06/2023
Date of last participant enrolment
Anticipated
31/12/2028
Actual
Date of last data collection
Anticipated
28/02/2034
Actual
Sample size
Target
168
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23585 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 23586 0
Epworth Eastern Hospital - Box Hill
Recruitment hospital [3] 23587 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 23588 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment postcode(s) [1] 39006 0
3065 - Fitzroy
Recruitment postcode(s) [2] 39007 0
3128 - Box Hill
Recruitment postcode(s) [3] 39008 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 301430 0
Hospital
Name [1] 301430 0
St Vincent's Hospital Research Endowment Fund
Country [1] 301430 0
Australia
Funding source category [2] 312691 0
Hospital
Name [2] 312691 0
Epworth Research Foundation
Country [2] 312691 0
Australia
Primary sponsor type
Individual
Name
Dr Mary Ann Johnson
Address
41 Victoria ParadeFitzroy VIC 3070
Country
Australia
Secondary sponsor category [1] 301116 0
None
Name [1] 301116 0
Address [1] 301116 0
Country [1] 301116 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302164 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 302164 0
https://svhs.org.au/home/research-education/research-office
Ethics committee country [1] 302164 0
Australia
Date submitted for ethics approval [1] 302164 0
11/01/2023
Approval date [1] 302164 0
22/02/2023
Ethics approval number [1] 302164 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89346 0
Dr Mary Ann Johnson
Address 89346 0
St Vincent's Hospital Melbourne 41 Victoria ParadeFitzroy VIC 3065
Country 89346 0
Australia
Phone 89346 0
+61 3 98957606
Fax 89346 0
Email 89346 0
[email protected]
Contact person for public queries
Name 89347 0
Dr Mary Ann Johnson
Address 89347 0
St Vincent's Hospital Melbourne 41 Victoria ParadeFitzroy VIC 3065
Country 89347 0
Australia
Phone 89347 0
+61 3 98957606
Fax 89347 0
Email 89347 0
[email protected]
Contact person for scientific queries
Name 89348 0
Dr Mary Ann Johnson
Address 89348 0
St Vincent's Hospital Melbourne 41 Victoria ParadeFitzroy VIC 3065
Country 89348 0
Australia
Phone 89348 0
+61 3 98957606
Fax 89348 0
Email 89348 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data collected to be used in analysis will be de-identified in re-identifiable form for individual participants. The analysed data will be pooled, therefore no individually identifiable components will be apparent in the final demographic and statistical analysis. Only pooled data results will be presented or published. All study documents and findings will be regarded as highly confidential, and will not be disclosed without prior written approval from the investigator.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.