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

NCT03429374 | Terminated

• 1 other identifier: BLITS-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 11

Brief 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. 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

Outcome Measures

Primary Outcomes (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.

  At 4 - 6 weeks

Secondary Outcomes (19)

• Period of hospitalization

  up to 5 days

• Operating time

  Intra-operatively

• Intra-operative adverse events

  Intra-operatively

• Post-operative adverse events

  up to 24 months follow-up

• Usability of the glue during the index-procedure

  Intra-operatively

Study Arms (2)

Liquiband Fix8 glue mesh fixation

ACTIVE COMPARATOR

Device: Liquiband Fix8

Mesh fixation with absorbable tacks

ACTIVE COMPARATOR

Device: Absorbable tack

Interventions

Liquiband Fix8 DEVICE

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.

Liquiband Fix8 glue mesh fixation

Absorbable tack DEVICE

Absorbable tack

Mesh fixation with absorbable tacks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Duomed: lead

Study Sites (11)

Hospital Network Antwerp (ZNA) Jan Palfijn

Antwerp, Belgium

Location

General Hospital Sint Jan Brugge

Bruges, Belgium

Location

University Hospital Brussels

Brussels, Belgium

Location

CHU Charleroi

Charleroi, Belgium

Location

General Hospital Sint Vincentius Deinze

Deinze, Belgium

Location

ZOL Genk

Genk, Belgium

Location

University Hospital Leuven

Leuven, Belgium

Location

CHR Namur

Namur, Belgium

Location

General Hospital Nikolaas

Sint-Niklaas, Belgium

Location

Regional Hospital HH Tienen

Tienen, Belgium

Location

General Hospital Delta Torhout

Torhout, Belgium

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients are randomly allocated to group 1 or group 2: * Group 1: Mesh fixation with tacks. * Group 2: Mesh fixation with glue.

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: February 12, 2018
• Study Start: November 19, 2018
• Primary Completion: May 20, 2021
• Study Completion: May 20, 2021
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (11)