Clinical trial NCT03429374: Tacks Versus Glue for Mesh Fixation in Laparoscopic Ventral Hernia Repair Treating Defects Between 2 and 5 cm Width
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: Duomed
Sponsor class: INDUSTRY
First posted: 2018-02-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomly allocated to group 1 or group 2:

* Group 1: Mesh fixation with tacks.
* Group 2: Mesh fixation with glue.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain in both groups at 4-6 weeks after LVHR using the Visual Analog Scale (VAS)
timeFrame: At 4 - 6 weeks
Secondary outcomes:
measure: Period of hospitalization
timeFrame: up to 5 days
measure: Operating time
timeFrame: Intra-operatively
measure: Intra-operative adverse events
timeFrame: Intra-operatively
measure: Post-operative adverse events
timeFrame: up to 24 months follow-up
measure: Usability of the glue during the index-procedure
timeFrame: Intra-operatively
measure: Technical success of glue fixation
timeFrame: Intra-operatively
measure: Technical success of tack fixation
timeFrame: Intra-operatively
measure: Pain at baseline using the VAS scale
timeFrame: At baseline
measure: Pain at discharge using the VAS scale
timeFrame: Up to 5 days
measure: Pain at 12 months follow-up using the VAS scale
timeFrame: At 12 months follow-up
measure: Pain at 24 months follow-up using the VAS scale
timeFrame: At 24 months follow-up
measure: Postoperative analgesic intake
timeFrame: Up to 24 months follow-up
measure: Postoperative analgesic intake
timeFrame: Up to 24 months follow-up
measure: Period to return to normal activity
timeFrame: At 4 - 6 weeks follow-up
measure: Quality of life at baseline.
timeFrame: At baseline
measure: Quality of life at 4-6 weeks.
timeFrame: At 4 - 6 weeks follow-up
measure: Quality of life at 12 months follow-up.
timeFrame: At 12 months follow-up
measure: Quality of life at 24 months follow-up.
timeFrame: At 24 months follow-up
measure: Recurrences during follow-up
timeFrame: up to 24 months follow-up
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Hospital Network Antwerp (ZNA) Jan Palfijn
city: Brugge
country: Belgium
facility: General Hospital Sint Jan Brugge
city: Brussels
country: Belgium
facility: University Hospital Brussels
city: Charleroi
country: Belgium
facility: CHU Charleroi
city: Deinze
country: Belgium
facility: General Hospital Sint Vincentius Deinze
city: Genk
country: Belgium
facility: ZOL Genk
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Namur
country: Belgium
facility: CHR Namur
city: Sint-Niklaas
country: Belgium
facility: General Hospital Nikolaas
city: Tienen
country: Belgium
facility: Regional Hospital HH Tienen
city: Torhout
country: Belgium
facility: General Hospital Delta Torhout
Study officials:
References: