Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000643875
Ethics application status
Approved
Date submitted
7/04/2021
Date registered
28/05/2021
Date last updated
16/11/2023
Date data sharing statement initially provided
28/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the repair of hernia in patients with a ventral hernia with either tacks or sutures improve pain and mobility of patients?
Scientific title
Laparoscopic Articulated Continuous Suture vs tacks in patients with a ventral hernia repair, a randomised controlled trial to assess pain and mobility post-operatively.
Secondary ID [1] 303897 0
JHGIS017
Universal Trial Number (UTN)
Trial acronym
ERACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
abdominal wall hernia 321476 0
post-operative pain 321477 0
Condition category
Condition code
Surgery 319745 319745 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Suture fixation of surgical mesh to the abdominal wall during repair of ventral hernia.
Procedure to be performed by a general surgeon who has completed at least 5 of these procedures as a consultant surgeon. Procedure duration is 30-60 minutes.
Intervention code [1] 320204 0
Treatment: Surgery
Comparator / control treatment
Tack fixation fixation of surgical mesh to the abdominal wall during repair of ventral hernia. Procedure to be performed by a general surgeon who has completed at least 5 of these procedures as a consultant surgeon. Procedure duration is 30-60 minutes.
Control group
Active

Outcomes
Primary outcome [1] 327106 0
The proportion of patients in each arm of the study who achieve 80% of their baseline pre-operative mobility score using the de Morton Mobility Index (DEMMI) score.
Timepoint [1] 327106 0
Assessed pre-operatively as a baseline compared to day 2 post-procedure, or the day of discharge if discharged prior to day 2.
Secondary outcome [1] 393815 0
Mean length of hospital stay (days).
Timepoint [1] 393815 0
As recorded by review of the medical record at day 30 post-procedure.
Secondary outcome [2] 393816 0
Mean post-operative pain score at day 2 post-procedure
Timepoint [2] 393816 0
As assessed using the Visual Analogue Scale on day 2 post-procedure reported by the participant in hospital.
Secondary outcome [3] 393817 0
Proportion of patients in each arm of the study who received scripts for opioid analgesia.
Timepoint [3] 393817 0
Assessed at discharge by review of medical records or as reported by patient.
Secondary outcome [4] 393818 0
Incidence of hernia recurrence.
Timepoint [4] 393818 0
Within 12 months of surgical procedure based on physical examination of participant and completion of patient reported hernia quality of life questionnaire.
Secondary outcome [5] 393819 0
Incidence of post-operative surgical complications graded by the Clavien-Dindo Classification of Surgical Complications
Timepoint [5] 393819 0
Up to post-operative day 30 as recorded in medical record and reported by patient via phone interview.
Secondary outcome [6] 393820 0
Mean abdominal wall hernia specific quality of life score as patient reported outcome (HerQLes Score).
Timepoint [6] 393820 0
Assessed at day 30 post-procedure.
Secondary outcome [7] 393823 0
Mean length of operative procedure.
Timepoint [7] 393823 0
As recorded in the medical record operative report reviewed at day 30 post procedure.

Eligibility
Key inclusion criteria
All patients undergoing an elective laparoscopic repair of ventral hernia will be included provided they meet the following criteria:
• Age 18 years or over
• Provide written consent to participate in the study
• Hernia defect size of 2-10cm as measured intra-operatively with insufflation pressure of 12mmHg
• Hernia considered suitable for laparoscopic repair with either suture or tack fixation of mesh by operating surgeon
• Proposed permanent coated mesh determined to be suitable for intra-peritoneal placement by the treating surgeon
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the trial if they meet the following exclusion criteria:
• Recurrent hernia with previous intraperitoneal mesh
• Known allergic reaction to bupivacaine or ropivacaine
• Large (>10cms) hernias not suitable for laparoscopic repair
• Umbilical defects most appropriate for open primary suture repair
• Incarcerated, strangulated or obstructed hernias booked as emergency cases.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
21/06/2021
Actual
23/07/2021
Date of last participant enrolment
Anticipated
31/12/2022
Actual
28/07/2022
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
100
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19066 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 19067 0
Belmont Hospital - Belmont
Recruitment postcode(s) [1] 33616 0
2305 - New Lambton
Recruitment postcode(s) [2] 33617 0
2280 - Belmont

Funding & Sponsors
Funding source category [1] 308286 0
Hospital
Name [1] 308286 0
John Hunter Hospital
Country [1] 308286 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
Lookout Road
New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 309091 0
None
Name [1] 309091 0
Address [1] 309091 0
Country [1] 309091 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308260 0
Hunter New Engand Human Research Ethics Committee
Ethics committee address [1] 308260 0
Ethics committee country [1] 308260 0
Australia
Date submitted for ethics approval [1] 308260 0
31/03/2021
Approval date [1] 308260 0
21/06/2021
Ethics approval number [1] 308260 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110114 0
Dr David Burnett
Address 110114 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 110114 0
Australia
Phone 110114 0
+61 2 49236397
Fax 110114 0
Email 110114 0
[email protected]
Contact person for public queries
Name 110115 0
Rosemary Carroll
Address 110115 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 110115 0
Australia
Phone 110115 0
+61 2 49236397
Fax 110115 0
Email 110115 0
[email protected]
Contact person for scientific queries
Name 110116 0
David Burnett
Address 110116 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 110116 0
Australia
Phone 110116 0
+61 2 49236397
Fax 110116 0
Email 110116 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
Post publication of study results up to 3 years after.
Available to whom?
Researchers who provide a methodologically sound proposal, and decided on a case-by-case basis at the discretion of Principal Investigator and fellow authors.
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
Contact PI via contact details in trial registration.


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.