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

Duomed

Status: Terminated

Conditions: Ventral Hernia

Treatments: Device: Absorbable tack; Device: Liquiband Fix8

Study type: Interventional

Funder types: Industry

Identifiers

NCT03429374

BLITS-01

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

16 participants in 2 patient groups

Liquiband Fix8 glue mesh fixation

Active Comparator group

Treatment:

Device: Liquiband Fix8

Mesh fixation with absorbable tacks

Active Comparator group

Treatment:

Device: Absorbable tack