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Aim of the study is to evaluate the risk reduction of intraperitoneal mesh-implementation after laparotomy (Group 1) in a randomized control trial compared with patients with standard abdominal closure (Everett-suture). This is the primary endpoint. Second endpoints are the feasibility of mesh-implementation even after colorectal surgery, find risk factors for wound infection and incisional hernia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Mesh | No Intervention | ||
| Mesh Implementation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesh implementation | Device | Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy | Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Mesh-implementation Even After Colorectal Surgery, Find Risk Factors for Wound Infection and Incisional Hernia. | Secondary endpoints are the feasibility, the safety of the mesh stripe implantation including postoperative pain, and the incidence of incisional hernias at 5 years. | 5 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Liestal | Liestal | Basel-Landschaft | 4410 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30824961 | Derived | Glauser PM, Brosi P, Speich B, Kaser SA, Heigl A, Rosenberg R, Maurer CA. Prophylactic Intraperitoneal Onlay Mesh Following Midline Laparotomy-Long-Term Results of a Randomized Controlled Trial. World J Surg. 2019 Jul;43(7):1669-1675. doi: 10.1007/s00268-019-04964-6. | |
| 29159603 | Derived | Brosi P, Glauser PM, Speich B, Kaser SA, Maurer CA. Prophylactic Intraperitoneal Onlay Mesh Reinforcement Reduces the Risk of Incisional Hernia, Two-Year Results of a Randomized Clinical Trial. World J Surg. 2018 Jun;42(6):1687-1694. doi: 10.1007/s00268-017-4363-2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Mesh | conventional abdominal closure with a suture |
| FG001 | Mesh Implementation | Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Mesh | The closure technique consisted of a single-layer continuous suture technique with picking up all layers of the abdominal wall apart from subcutaneous fat and skin (peritoneum, posterior rectus sheath, rectus muscle and anterior rectus sheath). |
| BG001 | Mesh Implementation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy | Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy. | Posted | Number | participants | 2 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Mesh | conventional abdominal closure with a suture | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bowel Fistulation | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Christoph A. Maurer | Hirslanden Bern | +41 31 335 33 33 | christoph.maurer@hin.ch |
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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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Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Feasibility of Mesh-implementation Even After Colorectal Surgery, Find Risk Factors for Wound Infection and Incisional Hernia. | Secondary endpoints are the feasibility, the safety of the mesh stripe implantation including postoperative pain, and the incidence of incisional hernias at 5 years. | Not Posted | Jun 2020 | 5 Years | Participants |
| 136 |
| 0 |
| 136 |
| 0 |
| 136 |
| EG001 | Mesh Implementation | Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia. | 4 | 131 | 0 | 131 | 2 | 131 |
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| D010335 | Pathologic Processes |