Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000742976
Ethics application status
Approved
Date submitted
9/06/2020
Date registered
16/07/2020
Date last updated
16/07/2020
Date data sharing statement initially provided
16/07/2020
Date results provided
16/07/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Glue vs. Tacks in Mesh Fixation for Minimally Invasive Inguinal Hernia Repair – A Randomised Controlled Trial
Scientific title
Cyanoacrylate Glue vs. Absorbable Tacks in Mesh Fixation for Laparoscopic Extra-Peritoneal Inguinal Hernia Repair – A Randomised Controlled Trial
Secondary ID [1] 301456 0
Nil known
Universal Trial Number (UTN)
U1111-1253-0929
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inguinal Hernia 317773 0
Condition category
Condition code
Surgery 315840 315840 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: mesh fixation methods in laparoscopic totally extra-peritoneal (TEP) inguinal hernia repair (IHR)

Why: there is controversy surrounding the ideal fixation method for mesh in laparoscopic hernia repair. The goal of this study was to compare different mesh fixation methods in TEP IHR with the primary outcome focusing on chronic post-operative inguinal pain, which is a known complication of IHR.

Arm 1: Absorbable tack fixation
*tacks made of an absorbable synthetic polyester copolymer. Intra-operatively, they are applied using a laparoscopic absorbable tack fixation device. Manufactured by Medtronic (NSW, Australia).

Arm 2: Cyanoacrylate glue fixation
* Glubran2 is a cyanoacrylate glue that is modified by the addition of a monomer synthesized by the manufacturer. Intra-operatively, it is applied using a laparoscopic glue application tool. Manufactured by Matrix Surgical (Clayton, VIC, Australia).

Procedures: each intervention arm involved patients aged 18 years or over, undergoing elective laparoscopic TEP IHR. Apart from mesh fixation, all other aspects of surgery and aftercare remained the same in both arm.

Who: eligible care providers were all General Surgeons who were fellows of the Royal Australasian College of Surgeons (RACS).

How: mesh fixation was performed intra-operatively on each patient enrolled in the study. It was performed by participating surgeons as described above.

Where: The interventions occurred at two centres, The Northern and Broadmeadows Hospitals. The Northern Hospital is a 400-bed tertiary health centre situated in Epping, Melbourne, Victoria, Australia. Broadmeadows Hospital is a smaller surgical health centre, located in Broadmeadows, Melbourne, Victoria, Australia. Both centres are part of the Northern Health Service, and provide tertiary health care to the metropolitan and rural communities of north-western Victoria.

When and How Much: Each intervention was performed once per hernia. In the case of patients who had bilateral hernia repairs in the same operation, each individual hernia was randomised separately to receive an intervention. The intervention occurred during the patient's operation, with no further interventions after the hernia repair.

Tailoring: interventions (mesh fixation methods) were not personalised, titrated or adapted to participants.

Modifications: interventions (mesh fixation methods) were not modified during the course of the study

How Well Planned/Actual: surgeon adherence to the correct method of cyanoacrylate glue mesh fixation was enhanced by the presence of the manufacturer’s representative during the operation. This did not occur during absorbable tack mesh fixation as it was considered the "standard-of-care" method.
Intervention code [1] 317767 0
Treatment: Surgery
Intervention code [2] 317919 0
Treatment: Devices
Comparator / control treatment
The control treatment was the absorbable tack mesh fixation. Details of this treatment can be found in the "Description of interventional exposure" section, according to the TIDieR Checklist.
Control group
Active

Outcomes
Primary outcome [1] 324045 0
Change in mean pain scores of participants at various time points before and after hernia repair via a questionnaire. Pain scores were assessed using validated tools for pain assessment, including a visual analogue scale (VAS) and numeric rating scale for pain, as part of the questionnaire.
Timepoint [1] 324045 0
Questionnaires were completed immediately prior to surgery, on day one post-surgery, on day fourteen post-surgery, on day ninety post-surgery (primary timepoint), and on day one-hundred and eighty post-surgery.
Secondary outcome [1] 383608 0
Several functional questions were included in the questionnaire relating to the impact of pain on activities of daily living. These were used to assess the quality of life as a secondary outcome measure of the study.
Timepoint [1] 383608 0
Questionnaires were completed immediately prior to surgery, on day one post-surgery, on day fourteen post-surgery, on day ninety post-surgery (primary timepoint), and on day one-hundred and eighty post-surgery.
Secondary outcome [2] 383609 0
Hernia recurrence, another secondary outcome measure, was also assessed using the questionnaire.
Timepoint [2] 383609 0
Questionnaires were completed immediately prior to surgery, on day one post-surgery, on day fourteen post-surgery, on day ninety post-surgery (primary timepoint), and on day one-hundred and eighty post-surgery.
Secondary outcome [3] 383610 0
Patient length of stay
Timepoint [3] 383610 0
This outcome was measured by calculating the number of days the participant spent admitted to hospital, from pre-operative admission until discharge after their operation.
Secondary outcome [4] 383611 0
Time taken to perform the operation
Timepoint [4] 383611 0
This outcome was recorded on the day of surgery, after the operation had been completed, by the performing surgeon.
Secondary outcome [5] 383612 0
Time taken to fix the mesh to the hernia defect.
Timepoint [5] 383612 0
This outcome was recorded on the day of surgery, after the operation had been completed, by the performing surgeon.
Secondary outcome [6] 383613 0
Location of where the fixation was applied on the mesh. This outcome was recorded on a standardised anatomical schematic diagram provided to surgeons prior to the operation. After completing the procedure, the operating surgeon would annotate the diagram with the various locations that the fixation material (glue or tacks) was applied. Fixation location was divided into "medial" and "lateral" fixation in relation to the inferior epigastric vessels.
Timepoint [6] 383613 0
This outcome was recorded on the day of surgery, after the operation had been completed, by the performing surgeon.

Eligibility
Key inclusion criteria
Patients 18 years of age or more who were undergoing elective laparoscopic totally extra-peritoneal inguinal hernia repair
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
High BMI, an inability to tolerate general anaesthesia, emergency repair, or patients with a history of pre-operative chronic pain on regular opioids or neuropathic agents.

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)
A sealed opaque envelope was used, thus ensuring appropriate allocation concealment from the chief investigator until after the questionnaire had been pulled from the envelope. The study envelope was stored within a secured office.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random sequence generation was performed through the use of a sealed opaque study envelope which contained questionnaires for either glue or tack fixation in a 1:1 ratio. Simple randomisation was performed by selecting a questionnaire from this envelope on the day of the participant’s surgery, once the participant was enrolled into the trial. This provided random allocation of the participant to one group of the trial. In the case of bilateral hernias, randomisation was completed separately for each hernia side.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size estimation considered a reduction in the mean VAS pain score of two points or greater as indicating clinical significance, leading to an effect size of 1.0, with standard deviation of 2.0. Assuming a 1:1 randomised allocation to each arm, a type I error rate of 0.05 and type II error rate of 0.2, a sample size of n = 63 was required to be recruited in each group

Analyses were conducted on an intention-to-treat basis, with patients only considered in the analysis who had a baseline pain score recorded. A repeated measures model was used to assess change in VAS score over time and differences within each group, assuming unstructured covariance for each outcome. Patients with bilateral hernias being operated on synchronously were considered as being clustered within patient, with results presented at a hernia level. Linear models were considered to assess VAS as a continuous score, with missing observations imputed with chained equations, using sex, age, ASA, laterality, hernia type and mesh type as variables to predict the missing values. Results were presented as means and standard deviations, with corresponding 95% confidence intervals also presented. Variables found to be significantly different at baseline across the two arms (i.e. age and ASA) were included as covariates. Sensitivity analyses were conducted to consider the exclusion of heterogeneous patients who had one tack and one glue procedure, along with an assessment of the effect of imputing missing observations over follow-up time-points. Statistical significance was set at p<0.05, with statistical analysis performed using Stata/SE version 15.1

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/10/2017
Date of last participant enrolment
Anticipated
Actual
1/04/2019
Date of last data collection
Anticipated
Actual
1/10/2019
Sample size
Target
126
Accrual to date
Final
122
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16844 0
The Northern Hospital - Epping
Recruitment hospital [2] 16846 0
Broadmeadows Health Service - Broadmeadows
Recruitment postcode(s) [1] 30489 0
3076 - Epping
Recruitment postcode(s) [2] 30491 0
3047 - Broadmeadows

Funding & Sponsors
Funding source category [1] 305892 0
Self funded/Unfunded
Name [1] 305892 0
Not applicable - unfunded
Country [1] 305892 0
Primary sponsor type
Individual
Name
Henry To
Address
Northern Hospital
185 Cooper Street
Epping, VIC 3076
Country
Australia
Secondary sponsor category [1] 306347 0
Individual
Name [1] 306347 0
Arun Dhir
Address [1] 306347 0
Northern Hospital
185 Cooper Street
Epping, VIC 3076
Country [1] 306347 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306150 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 306150 0
Ethics committee country [1] 306150 0
Australia
Date submitted for ethics approval [1] 306150 0
08/07/2017
Approval date [1] 306150 0
16/08/2017
Ethics approval number [1] 306150 0
HREC/17/Austin/337

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

Contacts
Principal investigator
Name 102882 0
Mr Henry To
Address 102882 0
The Northern Hospital
185 Cooper Street
Epping, VIC 3076
Country 102882 0
Australia
Phone 102882 0
+61 03 84058000
Fax 102882 0
Email 102882 0
[email protected]
Contact person for public queries
Name 102883 0
Henry To
Address 102883 0
The Northern Hospital
185 Cooper Street
Epping, VIC 3076
Country 102883 0
Australia
Phone 102883 0
+61 03 84058000
Fax 102883 0
Email 102883 0
[email protected]
Contact person for scientific queries
Name 102884 0
Henry To
Address 102884 0
The Northern Hospital
185 Cooper Street
Epping, VIC 3076
Country 102884 0
Australia
Phone 102884 0
+61 03 84058000
Fax 102884 0
Email 102884 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


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
SourceTitleYear of PublicationDOI
EmbaseCyanoacrylate glue versus absorbable tacks in mesh fixation for laparoscopic extraperitoneal inguinal hernia repair: A randomized controlled trial.2021https://dx.doi.org/10.1097/SLE.0000000000000915
N.B. These documents automatically identified may not have been verified by the study sponsor.