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| ID | Type | Description | Link |
|---|---|---|---|
| 200-06-005 |
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| Name | Class |
|---|---|
| Region Skane | OTHER |
| Lund University | OTHER |
| Ethicon, Inc. | INDUSTRY |
| The Einar & Inga Nilsson Foundation |
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This purpose of this study is to compare the recovery after an operation of an incisional hernia within the limits of the rectus muscles of the abdominal wall. The use of a mesh in the repair of a postoperative hernia is considered obligatory. Placement of a retromuscular mesh is done by open or laparoscopic surgery. Focus is on the recovery phase assuming a less painful recovery after a laparoscopic procedure.
Incisional ventral hernia after abdominal surgery is a fairly common condition. In recent years the use of a prosthesis in the repair procedure has proved very effective in preventing a new hernia. A retromuscular mesh placement seems to have superior results. The mesh may be placed retromuscular through an open surgical procedure or through a laparoscopic procedure in an intra-abdominal position. Both procedures are highly standardized. A heavy weight mesh is used in the open procedure, fixed in the midline only, and a composite mesh is used intraabdominally and fixed only with titanium tackers.
SF-36 is used to assess the quality of life, and its subscale BP (bodily pain) is used as primary outcome 3 weeks postoperatively. Secondary endpoints are return to daily life, pain, complications, recurrence, patient satisfaction and cosmetic outcome.
Subjects are assessed at 1,3,8 weeks post operation and after 12 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retromuscular Mesh repair of midline incisional hernia | Procedure | |||
| Laparoscopic repair of midline incisional hernia | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain recorded in SF-36 | Pain measured 3 weeks after surgery in SF36 subscale Bodily Pain | 3 weeks after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients referred to specialist centers for treatment of midline incisional hernias.
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| Name | Affiliation | Role |
|---|---|---|
| Agneta Montgomery, MD, PhD | Malmo University Hospital, Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malmö University Hospital, Department of Surgery | Malmö | Malmö | 20502 | Sweden | ||
| Arvika Hospital, Department of Surgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28634690 | Derived | Rogmark P, Ekberg O, Montgomery A. Long-term retromuscular and intraperitoneal mesh size changes within a randomized controlled trial on incisional hernia repair, including a review of the literature. Hernia. 2017 Oct;21(5):687-696. doi: 10.1007/s10029-017-1624-9. Epub 2017 Jun 20. | |
| 23629524 | Derived | Rogmark P, Petersson U, Bringman S, Eklund A, Ezra E, Sevonius D, Smedberg S, Osterberg J, Montgomery A. Short-term outcomes for open and laparoscopic midline incisional hernia repair: a randomized multicenter controlled trial: the ProLOVE (prospective randomized trial on open versus laparoscopic operation of ventral eventrations) trial. Ann Surg. 2013 Jul;258(1):37-45. doi: 10.1097/SLA.0b013e31828fe1b2. |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
| The Anna-Lisa & Sven-Eric Lundgren Foundation, Malmö Sweden | OTHER |
| Crafoord Foundation | OTHER |
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| Arvika |
| SE-671 80 |
| Sweden |
| Helsingborg Hospital, Department of Surgery | Helsingborg | 251 87 | Sweden |
| Lund University Hospital, Department of Surgery | Lund | SE-222 41 | Sweden |
| Mora Hospital, Department of Surgery | Mora | SE-792 85 | Sweden |
| Södertälje Hospital, Department of Surgery | Södertälje | SE-152 86 | Sweden |
| Västerås Central Hospital, Department of Surgery | Västerås | SE-721 89 | Sweden |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |