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This is a prospective randomized study to compare surgical methods for the repair of large abdominal hernia.
Patients with giant (>10 cm in diameter) abdominal wall hernia are included in a prospective randomized study comparing conventional mesh repair with the best possible method to onlay full thickness skin grafts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hernia repair using full-thickness skin graft | Experimental | 25 patients |
|
| Hernia repair using Mesh | Experimental | 25 patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventral hernia repair using full thickness skin graft | Procedure | 25 patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complication | Complications will be assessed over a 3 year period of regular follow-up by an objective surgeon who is unaware of which surgical method which was used. Eventual complications may include infection, bleeding, seroma and fistula formation. | 3 month, 1 year and 3 year post-operative clinical follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Ventral Hernia Pain Questionnaire (VHPQ) | All subjects will complete the VHPQ which will be used to assess their pre- and postoperative pain. | 1 year period of follow-up |
| Abdominal wall function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karin Strigård, MD | Karolinska Institute CLINTEC | Study Director |
| Leonard Clay, MD | Karolinska Institute CLINTEC | Principal Investigator |
| Ulf Gunnarsson, MD | Karolinska Institute CLINTEC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34905143 | Derived | Holmdahl V, Stark B, Clay L, Gunnarsson U, Strigard K. Long-term follow-up of full-thickness skin grafting in giant incisional hernia repair: a randomised controlled trial. Hernia. 2022 Apr;26(2):473-479. doi: 10.1007/s10029-021-02544-z. Epub 2021 Dec 14. | |
| 29247365 | Derived | Clay L, Stark B, Gunnarsson U, Strigard K. Full-thickness skin graft vs. synthetic mesh in the repair of giant incisional hernia: a randomized controlled multicenter study. Hernia. 2018 Apr;22(2):325-332. doi: 10.1007/s10029-017-1712-x. Epub 2017 Dec 15. |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Ventral hernia repair using mesh | Procedure | 25 patients |
|
All subjects will undergo testing of abdominal wall function and strength using the Biodex.
| 3 year period of follow up |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |