Ventral Hernia
Conditions
Brief summary
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.
Detailed description
see brief summary
Interventions
PROCEDURElaparoscopic ventral herniotomy
Laparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally. Fixation of the mesh is performed with 1 of 3 possible devices
DEVICEProtack
fixation of mesh with protack
DEVICESecurestrap
fixation of mesh with Securestrap
DEVICEGlubran
fixation of mesh with Glubran
Sponsors
Randers Regional Hospital
Horsens Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* ventral hernia 2(1,5) \< dia \> 7 cm * danish speaking * of sound mind * bmi \< 35 * ASA 3 or less, no contra indication against laparoscopy
Exclusion criteria
* other size hernias, * no danish, * bmi \> 35
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | 1 measurement, 2nd postoperative day | Dolo Test (VAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hernia recurrence | 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60 | clinical examination and perhaps CT scan |
| quality of life | 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60 | SF 36 and Carolina's Comfort Scale |
| Pain | 7 measurements, day 1, 3 and 4 and postoperative month 1, 6, 12, 24 | Dolo Test(VAS) |
Countries
Denmark
Outcome results
None listed