Trials / Terminated
TerminatedNCT03429374
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
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Duomed · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DEVICE | Absorbable tack | Absorbable tack |
Timeline
- Start date
- 2018-11-19
- Primary completion
- 2021-05-20
- Completion
- 2021-05-20
- First posted
- 2018-02-12
- Last updated
- 2021-05-24
Locations
11 sites across 1 country: Belgium
Source: ClinicalTrials.gov record NCT03429374. Inclusion in this directory is not an endorsement.