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| Name | Class |
|---|---|
| Tyco Healthcare Group | INDUSTRY |
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The study aims to prove differences or equalities in outcome for patients operated with laparoscopic ventral hernia repair with different methods of fixation of mesh and with or without approximation of defect prior to meshfixation.
Patients are randomized to 4 groups: non-absorbable suture fixation and hernia approximation, double crown mesh fixation with titanium spiral tacks with hernia approximation and the same fixations without hernia approximation.
Primary endpoint is recurrence. Secondary endpoints are operating time, adhesion score, mode of entering abdominal cavity, time to recovery, pain durance, seroma formation, aesthetic result (protrusion), organ traumatization infection. Endpoints are correlated to hernia size, body mass index, previous recurrence, age, concurrent illness. Patients are followed 3 years after operation with clinical examination.
300 patients are planned included in primary study. A subgroup of organ transplanted patients is evaluated in a separate study with identical criteria for inclusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| a | Active Comparator | a: suture anchoring + tackers and approximation of defect |
|
| b | Active Comparator | b: suture anchoring + tackers without approximation of defect |
|
| c | Active Comparator | c: only tacker fixation and approximation of defect |
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| d | Active Comparator | d: only tacker fixation without approximation of defect |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic ventral hernia repair | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operating time | 30-180 min | |
| Adhesion score | ||
| Mode of entering abdominal cavity | ||
| Pain durance | 8 weeks | |
| Seroma formation | ||
| Aesthetic result (protrusion) | 3 years | |
| Infection | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Lambrecht, MD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SIHF GjĂžvik | GjĂžvik | Norway | ||||
| UllevÄl University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25663605 | Derived | Lambrecht JR, Vaktskjold A, Trondsen E, Oyen OM, Reiertsen O. Laparoscopic ventral hernia repair: outcomes in primary versus incisional hernias: no effect of defect closure. Hernia. 2015 Jun;19(3):479-86. doi: 10.1007/s10029-015-1345-x. Epub 2015 Feb 7. | |
| 24684675 | Derived | Lambrecht JR, Skauby M, Trondsen E, Vaktskjold A, Oyen OM. Laparoscopic repair of incisional hernia in solid organ-transplanted patients: the method of choice? Transpl Int. 2014 Jul;27(7):712-20. doi: 10.1111/tri.12327. Epub 2014 May 9. |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Oslo |
| Norway |