Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Randers Regional Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fixation with Protack | Experimental |
| |
| fixation with Securestrap | Experimental |
| |
| fixation with Glubran | Experimental | surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic ventral herniotomy | Procedure | Laparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally. Fixation of the mesh is performed with 1 of 3 possible devices |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Dolo Test (VAS) | 1 measurement, 2nd postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| hernia recurrence | clinical examination and perhaps CT scan | 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60 |
| quality of life | SF 36 and Carolina's Comfort Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sanne S Harsløf, MD | Regionshospitalet Horsens | Study Chair |
| Thorbjørn Sommer, MD, PhD | Randers Regional Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Hospital Horsens | Horsens | 8700 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29799075 | Derived | Harslof S, Krum-Moller P, Sommer T, Zinther N, Wara P, Friis-Andersen H. Effect of fixation devices on postoperative pain after laparoscopic ventral hernia repair: a randomized clinical trial of permanent tacks, absorbable tacks, and synthetic glue. Langenbecks Arch Surg. 2018 Jun;403(4):529-537. doi: 10.1007/s00423-018-1676-z. Epub 2018 May 25. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Protack | Device | fixation of mesh with protack |
|
| Securestrap | Device | fixation of mesh with Securestrap |
|
| Glubran | Device | fixation of mesh with Glubran |
|
| 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60 |
| Pain | Dolo Test(VAS) | 7 measurements, day 1, 3 and 4 and postoperative month 1, 6, 12, 24 |