Status:
TERMINATED
Tacks Versus Glue for Mesh Fixation in Laparoscopic Ventral Hernia Repair Treating Defects Between 2 and 5 cm Width
Lead Sponsor:
Duomed
Conditions:
Ventral Hernia
Eligibility:
All Genders
18+ years
Phase:
NA
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 ab...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03429374
Start Date
November 19 2018
End Date
May 20 2021
Last Update
May 24 2021
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Network Antwerp (ZNA) Jan Palfijn
Antwerp, Belgium
2
General Hospital Sint Jan Brugge
Bruges, Belgium
3
University Hospital Brussels
Brussels, Belgium
4
CHU Charleroi
Charleroi, Belgium