ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Massive ventral hernia

Condition category

Condition code

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

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]

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]

Hernia recurrence as assessed by the Principal Investigator by physical assessment (height and weight, abdominal examination) and imaging studies (computed tomography (CT)).

Timepoint [1]

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]

Pain as assessed by the 10-point pain Visual Analog Scale

Timepoint [1]

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]

Effect of hernia on quality of life will be assessed using the HerQles: Hernia related Quality of Life Survey.

Timepoint [2]

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]

Effect of hernia on quality of life will be assessed using the SF-36: Short form 36 item survey.

Timepoint [3]

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]

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]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [2]

Epworth Eastern Hospital - Box Hill

Recruitment hospital [3]

Box Hill Hospital - Box Hill

Recruitment hospital [4]

Royal Melbourne Hospital - Royal Park campus - Parkville

Recruitment postcode(s) [1]

3065 - Fitzroy

Recruitment postcode(s) [2]

3128 - Box Hill

Recruitment postcode(s) [3]

3052 - Parkville

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St Vincent's Hospital Research Endowment Fund

Address [1]

41 Victoria Parade, Fitzroy Victoria 3070

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Epworth Research Foundation

Address [2]

89 Bridge Rd, Richmond VIC 3121

Country [2]

Australia

Primary sponsor type

Individual

Name

Dr Mary Ann Johnson

Address

41 Victoria ParadeFitzroy VIC 3070

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent’s Hospital Human Research Ethics Committee

Ethics committee address [1]

https://svhs.org.au/home/research-education/research-office

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/01/2023

Approval date [1]

22/02/2023

Ethics approval number [1]

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

Dr Mary Ann Johnson

Address

St Vincent's Hospital Melbourne 41 Victoria ParadeFitzroy VIC 3065

Country

Australia

Phone

+61 3 98957606

Fax

mary.johnson@svha.org.au

Contact person for public queries

Name

Mary Ann Johnson

Address

St Vincent's Hospital Melbourne 41 Victoria ParadeFitzroy VIC 3065

Country

Australia

Phone

+61 3 98957606

Fax

mary.johnson@svha.org.au

Contact person for scientific queries

Name

Mary Ann Johnson

Address

St Vincent's Hospital Melbourne 41 Victoria ParadeFitzroy VIC 3065

Country

Australia

Phone

+61 3 98957606

Fax

mary.johnson@svha.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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