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

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: Terminated
• Conditions: Ventral Hernia
• Intervention / Treatment: Device: Liquiband Fix8; Device: Absorbable tack

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	At 4 - 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Period of hospitalization	Record the number of days in hospital until discharge	up to 5 days
Operating time		Intra-operatively
Intra-operative adverse events	Intra-operative adverse events include bleeding and enterotomy	Intra-operatively
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	up to 24 months follow-up
Usability of the glue during the index-procedure	Usability scoring: 1 = bad -> 3 = moderate -> 5 = excellent	Intra-operatively
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.	Intra-operatively
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.	Intra-operatively
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.	At baseline
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.	Up to 5 days
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.	At 12 months follow-up
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.	At 24 months follow-up
Postoperative analgesic intake	Period of intake	Up to 24 months follow-up
Postoperative analgesic intake	Type of intake	Up to 24 months follow-up
Period to return to normal activity	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.	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.	CCS questionnaire	At 4 - 6 weeks follow-up
Quality of life at 12 months follow-up.	CCS questionnaire	At 12 months follow-up
Quality of life at 24 months follow-up.	CCS questionnaire	At 24 months follow-up
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.	up to 24 months follow-up

Collaborators and Investigators

• Sponsor: Duomed

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2018
• Primary Completion (Actual): May 20, 2021
• Study Completion (Actual): May 20, 2021

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID 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