Tacks Versus Glue for Mesh Fixation in Laparoscopic Ventral Hernia Repair Treating Defects Between 2 and 5 cm Width

May 20, 2021 updated by: Duomed

Tacks Versus Glue for Mesh Fixation in Laparoscopic Ventral Hernia Repair Treating Defects Between 2 and 5 cm Width: a Multicenter Randomized Controlled Study

In laparoscopic ventral hernia repair, an abundance of methods has been developed to fix the mesh to the abdominal wall, including sutures (non-absorbable or absorbable), staples (non-absorbable or absorbable), clips, tacks (non-absorbable or absorbable) and (fibrin and synthetic) glues. Which fixation technique is superior, is still under evaluation. There is clearly a need for larger trials to obtain confident results on the safety and performance of glue mesh fixation and tack mesh fixation in LVHR. The hypothesis of this prospective, randomized controlled study is that post-operative pain at 4 to 6 weeks after mesh fixation with glue (LiquiBand® Fix 8™) will not differ compared to treatment with absorbable tacks during LVHR. A total of 510 patients will be recruited for this trial. This study will assess: pain, hernia recurrence, safety, procedural characteristics, technical success, analgesic intake, period to return to normal activity and quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium
        • Hospital Network Antwerp (ZNA) Jan Palfijn
      • Brugge, Belgium
        • General Hospital Sint Jan Brugge
      • Brussels, Belgium
        • University Hospital Brussels
      • Charleroi, Belgium
        • CHU Charleroi
      • Deinze, Belgium
        • General Hospital Sint Vincentius Deinze
      • Genk, Belgium
        • ZOL GENK
      • Leuven, Belgium
        • University Hospital Leuven
      • Namur, Belgium
        • CHR Namur
      • Sint-Niklaas, Belgium
        • General Hospital Nikolaas
      • Tienen, Belgium
        • Regional Hospital HH Tienen
      • Torhout, Belgium
        • General Hospital Delta Torhout

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient with ventral hernia (primary or incisional) with a defect size between 2 and 5 cm and eligible for laparoscopic repair.
  2. Patients with ASA grade I to III.
  3. Patient is at least 18 years old.
  4. Patient must sign and date the informed consent form prior to treatment.

Exclusion Criteria:

  1. Patient with a recurrence of a previously treated ventral hernia repaired with mesh. Recurrences are only allowed to be included after former primary (suture) repair or retromuscular/onlay mesh repair.
  2. Patient is treated by open surgery.
  3. Patient has more than one defect. Treatment of Swiss-cheese defects (multiple small defects) is allowed if all defects can be treated with one mesh. Total width cannot exceed 5 cm.
  4. Patient with a complex hernia, likely not eligible for laparoscopic repair. Complexity is determined by the investigator (adhesions, small bowel resection, etc).
  5. Patient with a life expectancy of less than 2 years.
  6. Patient is suspected of being unable to comply with the study protocol.
  7. Patient with severe chronic obstructive pulmonary disease.
  8. Patient with ASA IV or V.
  9. Patient is pregnant.
  10. Patient needs acute surgery.
  11. Patient is scheduled for surgery within 6 weeks after the index-procedure.
  12. Patient has fibromyalgia.
  13. Patient with depression as shown in patient medical record.
  14. Patient is enrolled in another study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Liquiband Fix8 glue mesh fixation
Device: Liquiband Fix8
LiquiBand® Fix 8™ (Advanced Medical Solutions - Plymouth, UK) is a hernia mesh fixation device providing strong and secure mesh fixation without causing any tissue damage or mechanical trauma. This device is designed to offer precise and controlled delivery of tissue glue (n-butyl-2-cyanoacrylate), resulting in a strong mesh fixation.
Active Comparator: Mesh fixation with absorbable tacks
Device: Absorbable tack
Absorbable tack

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain in both groups at 4-6 weeks after LVHR using the Visual Analog Scale (VAS)
Time Frame: At 4 - 6 weeks
The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain. The patient is asked to select the number on the scale that corresponds to the worst level of pain he/she experiences. Pain is classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm). Absence of pain is defined as VAS = 0.
At 4 - 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Period of hospitalization
Time Frame: up to 5 days
Record the number of days in hospital until discharge
up to 5 days
Operating time
Time Frame: Intra-operatively
Intra-operatively
Intra-operative adverse events
Time Frame: Intra-operatively
Intra-operative adverse events include bleeding and enterotomy
Intra-operatively
Post-operative adverse events
Time Frame: up to 24 months follow-up
Post-operative adverse events include seroma (i.e. accumulation of wound fluid), ileus (i.e. bowel obstruction), infection, bowel injury, major bleeding requiring blood transfusion or re-intervention, complications due to anesthesia and minor bleeding at a trocar insertion site
up to 24 months follow-up
Usability of the glue during the index-procedure
Time Frame: Intra-operatively
Usability scoring: 1 = bad -> 3 = moderate -> 5 = excellent
Intra-operatively
Technical success of glue fixation
Time Frame: Intra-operatively
During the index-procedure, the investigator will register whether fixation of the mesh with glue achieved technical success or not. Technical success is defined as successful hernia repair as intended.
Intra-operatively
Technical success of tack fixation
Time Frame: Intra-operatively
During the index-procedure, the investigator will register whether fixation of the mesh with tacks achieved technical success or not. Technical success is defined as successful hernia repair as intended.
Intra-operatively
Pain at baseline using the VAS scale
Time Frame: At baseline
The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain.
At baseline
Pain at discharge using the VAS scale
Time Frame: Up to 5 days
The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain.
Up to 5 days
Pain at 12 months follow-up using the VAS scale
Time Frame: At 12 months follow-up
The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain.
At 12 months follow-up
Pain at 24 months follow-up using the VAS scale
Time Frame: At 24 months follow-up
The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain.
At 24 months follow-up
Postoperative analgesic intake
Time Frame: Up to 24 months follow-up
Period of intake
Up to 24 months follow-up
Postoperative analgesic intake
Time Frame: Up to 24 months follow-up
Type of intake
Up to 24 months follow-up
Period to return to normal activity
Time Frame: At 4 - 6 weeks follow-up
Number of days after the index-procedure at which the patient resumes normal activities.
At 4 - 6 weeks follow-up
Quality of life at baseline.
Time Frame: At baseline
The Carolinas Comfort Scale questionnaire is a validated, disease-specific, quality of life questionnaire developed for patients undergoing hernia repair with mesh. It is a 23-item questionnaire that measures severity of pain, sensation, and movement limitations from the mesh in eight categories. The CCS score is derived by adding the scores from each of the 23 items. The best possible score is 0 and the worst possible score is 115.
At baseline
Quality of life at 4-6 weeks.
Time Frame: At 4 - 6 weeks follow-up
CCS questionnaire
At 4 - 6 weeks follow-up
Quality of life at 12 months follow-up.
Time Frame: At 12 months follow-up
CCS questionnaire
At 12 months follow-up
Quality of life at 24 months follow-up.
Time Frame: At 24 months follow-up
CCS questionnaire
At 24 months follow-up
Recurrences during follow-up
Time Frame: up to 24 months follow-up
A clinical examination is conducted to evaluate recurrence. If there is any suspicion of recurrence, an ultrasound or MRI is performed according to hospital practice to distinguish true recurrences from bulging.
up to 24 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duomed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BLITS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ventral Hernia

Clinical Trials on Liquiband Fix8

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings