Clinical, controlled, randomized, prospective study. Ventral hernias between 2(1.5)cm and 7 cm, laparoscopic surgery with intraperitoneal onlay mesh. Three randomization groups of 25 patients giving a total of 75 patients. Mesh is fixated with either Protack, Securestrap or Glubran II. Primary outcome: postoperative pain on the 2nd postoperative day. Secondary outcomes: pain, quality of life, recurrence and adhesions at 1, 6, 12, 24, 36, 48 and 60 months postoperative.
see brief summary
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
75
Laparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally. Fixation of the mesh is performed with 1 of 3 possible devices
fixation of mesh with protack
fixation of mesh with Securestrap
Regional Hospital Horsens
Horsens, Denmark
Pain
Dolo Test (VAS)
Time frame: 1 measurement, 2nd postoperative day
hernia recurrence
clinical examination and perhaps CT scan
Time frame: 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60
quality of life
SF 36 and Carolina's Comfort Scale
Time frame: 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60
Pain
Dolo Test(VAS)
Time frame: 7 measurements, day 1, 3 and 4 and postoperative month 1, 6, 12, 24
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fixation of mesh with Glubran