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Incisional hernias are primarily repaired using prosthetic meshes. In Switzerland such meshes are mainly implanted via open or laparoscopic approach. The differential impact of these two types of surgical technique on recurrence rate will be investigated with this study.
With this multicenter cohort study the outcomes of laparoscopic and open incisional hernia repair will be investigated prospectively. Hernia recurrence is the main outcome measure.
Background
Incisional hernia is one of the most common complication in general abdominal surgery. An overall incidence of 20% has been found in retrospective studies, ranging in up to 50% of patients with selected risk factors such as obesity.
In the general surgical patient the current standard is the closure of the abdominal wall using a running, slowly absorbable suture. With this well established clinical practice the incidence remains high and incisional hernia repair must be performed frequently in order to treat patients'symptoms and to prevent progression of the hernia an possible complications.
Consequently, in high risk patients prophylactic mesh implantation is performed routinely in our institution.
Objective
Occurrence of at least two of the following factors:
Elective operation
Patient >18 years
Written informed consent
Methods
Prospective,two armed, controlled, randomized study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | The main operation will be performed as planned. For the closure of the abdominal wall, a standard technique will be applied using a running suture of PDS 1 loop. The distance of the sutures to the fascial border is 1cm and the distance between two stitches is not more than 1cm. The total length of suture is at least 4 times the total length of the abdominal incision |
| |
| Treatment Group | The main operation will be performed as planned. Prior to the closure of the abdominal wall a mesh will be implanted in a standardized fashion: A Dynamesh IPOM mesh will be used for the present study. The mesh has a width of 15cm and is tailored to overlap lateral and cranial boarders at least 5cm. The mesh will be placed intra-abdominally and fixed using intra-abdominal stitches using Prolene 2/0 in all four corners. After the initial fixation of the mesh in all quadrants, the boarders of the mesh will be adapted using Prolene 2/0 running sutures. The fixation aims to prevent any intestinal structures to herniate onto the mesh. Afterwards, the abdominal wall is closed as described in the control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal surgery | Procedure | Intraoperative mesh implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of incisional hernia | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Direct in-hospital costs | 3 years | |
| Intraoperative complications | 3 years | |
| Postoperative complications |
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Inclusion Criteria:
Occurrence of at least two of the following factors:
Elective operation
Patient > 18 years
Written informed consent
Exclusion Criteria
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Population with a high risk for incisional hernia formation
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| Name | Affiliation | Role |
|---|---|---|
| Guido Beldi, Prof. Dr. med. | Berne, University Hospital, Univesrity of Berne, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of Visceral and transplant surgery, Berne University Hospital | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30476940 | Derived | Kohler A, Lavanchy JL, Lenoir U, Kurmann A, Candinas D, Beldi G. Effectiveness of Prophylactic Intraperitoneal Mesh Implantation for Prevention of Incisional Hernia in Patients Undergoing Open Abdominal Surgery: A Randomized Clinical Trial. JAMA Surg. 2019 Feb 1;154(2):109-115. doi: 10.1001/jamasurg.2018.4221. |
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| ID | Term |
|---|---|
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| 3 years |
| D010335 | Pathologic Processes |