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Ventral HerniaNCT03429374

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

A study testing Liquiband Fix8 and Absorbable tack in people with Ventral Hernia, run by Duomed at 11 sites in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ventral Hernia
What is being tested?
Liquiband Fix8 and Absorbable tack
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
11 sitesBelgium
Study dates
19 Nov 2018to 20 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
  • Patient is treated by open surgery.
  • 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.
  • Patient with a complex hernia, likely not eligible for laparoscopic repair. Complexity is determined by the investigator (adhesions, small bowel resection, etc).
  • Patient with a life expectancy of less than 2 years.
  • Patient is suspected of being unable to comply with the study protocol.
Show all 14Show fewer
  • Patient with severe chronic obstructive pulmonary disease.
  • Patient with ASA IV or V.
  • Patient is pregnant.
  • Patient needs acute surgery.
  • Patient is scheduled for surgery within 6 weeks after the index-procedure.
  • Patient has fibromyalgia.
  • Patient with depression as shown in patient medical record.
  • Patient is enrolled in another study.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Belgium11 sites

  • Hospital Network Antwerp (ZNA) Jan Palfijn

    Antwerp

  • General Hospital Sint Jan Brugge

    Bruges

  • University Hospital Brussels

    Brussels

  • CHU Charleroi

    Charleroi

  • General Hospital Sint Vincentius Deinze

    Deinze

  • ZOL Genk

    Genk

  • University Hospital Leuven

    Leuven

  • CHR Namur

    Namur

  • General Hospital Nikolaas

    Sint-Niklaas

  • Regional Hospital HH Tienen

    Tienen

  • General Hospital Delta Torhout

    Torhout

Other trials in Belgium

About this study

Official title: 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.

Conditions
Ventral Hernia
Being tested
Liquiband Fix8, Absorbable tack
Medical subject headings
Hernia, Ventral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liquiband Fix8Device

    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.

  • Absorbable tackDevice

    Absorbable tack

Study groups in NCT03429374
Study groupRoleWhat they receive
Liquiband Fix8 glue mesh fixationActive comparatorNot described
Receives: Device: Liquiband Fix8
Mesh fixation with absorbable tacksActive comparatorNot described
Receives: Device: Absorbable tack

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain in both groups at 4-6 weeks after LVHR using the Visual Analog Scale (VAS)

    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.

    Measured: At 4 - 6 weeks

Secondary outcomes (19)

  1. Period of hospitalization

    Record the number of days in hospital until discharge

    Measured: up to 5 days

  2. Operating time

    Measured: Intra-operatively

  3. Intra-operative adverse events

    Intra-operative adverse events include bleeding and enterotomy

    Measured: Intra-operatively

  4. Post-operative adverse events

    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

    Measured: up to 24 months follow-up

  5. Usability of the glue during the index-procedure

    Usability scoring: 1 = bad -> 3 = moderate -> 5 = excellent

    Measured: Intra-operatively

  6. Technical success of glue fixation

    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.

    Measured: Intra-operatively

  7. Technical success of tack fixation

    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.

    Measured: Intra-operatively

  8. Pain at baseline using the VAS scale

    The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain.

    Measured: At baseline

  9. Pain at discharge using the VAS scale

    The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain.

    Measured: Up to 5 days

  10. Pain at 12 months follow-up using the VAS scale

    The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain.

    Measured: At 12 months follow-up

  11. Pain at 24 months follow-up using the VAS scale

    The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain.

    Measured: At 24 months follow-up

  12. Postoperative analgesic intake

    Period of intake

    Measured: Up to 24 months follow-up

  13. Postoperative analgesic intake

    Type of intake

    Measured: Up to 24 months follow-up

  14. Period to return to normal activity

    Number of days after the index-procedure at which the patient resumes normal activities.

    Measured: At 4 - 6 weeks follow-up

  15. Quality of life 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.

    Measured: At baseline

  16. Quality of life at 4-6 weeks.

    CCS questionnaire

    Measured: At 4 - 6 weeks follow-up

  17. Quality of life at 12 months follow-up.

    CCS questionnaire

    Measured: At 12 months follow-up

  18. Quality of life at 24 months follow-up.

    CCS questionnaire

    Measured: At 24 months follow-up

  19. Recurrences during 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.

    Measured: up to 24 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2018
  2. Study start19 Nov 2018
  3. Primary completion20 May 2021
  4. Study completion20 May 2021

Why it stopped: Limited patient enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients are randomly allocated to group 1 or group 2: * Group 1: Mesh fixation with tacks. * Group 2: Mesh fixation with glue.
Masking
Single blind
Who is masked
Participant
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03429374
Sponsor's protocol ID
BLITS-01
Status last verified
May 2021
First submitted
9 Jan 2018
Last updated
24 May 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Liquiband Fix8 and Absorbable tack in people with Ventral Hernia, run by Duomed at 11 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Limited patient enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain in both groups at 4-6 weeks after LVHR using the Visual Analog Scale (VAS) (time frame: At 4 - 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03429374.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.

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