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Patients undergoing primary midline laparotomy for an emergency surgical intervention with a suspected septic focus in the abdominal cavity.
More than 700.000 open abdominal surgeries (laparotomies) are performed each year in Germany (2). A major surgical complication after laparotomy is abdominal fascia dehiscence which might appear either as early (burst abdomen with evisceration) or as late complication (incisional hernia). These patients usually undergo surgery for secondary fascial closure associated with markedly increased morbidity (3) including high recurrence rates (up to 45%) (4). The applied surgical strategy of abdominal wall closure (i.e. the combination of suture technique and material) is of high relevance for prevention of fascia dehiscence and, moreover, constitutes the main factor directly controllable by the surgeon. While several randomized controlled trials (RCT) (3; 5-8) as well as meta-analyses (9-12) exist that address the issue of optimal fascia closure in elective laparotomies, there is no RCT dealing exclusively with the emergency setting. As a result abdominal fascia closure is performed according to the surgeon's individual preference rather than according to evidence-based data. Therefore, the present RCT is designed to compare the most established strategies (continuous slowly absorbable sutures and interrupted rapidly absorbable sutures) for abdominal wall closure in order to determine differences between both strategies after midline incisions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Interrupted closure with Vicryl equivalent sutures (USP 2, 45 cm) |
|
| B | Experimental | Continuous closure with PDS II equivalent sutures (USP 1, 150 cm loops) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interrupted sutures | Procedure | Interrupted sutures for abdominal fascia closure with Vicryl equivalent sutures (USP 2, 45 cm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incisional hernia or burst abdomen within 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | 12 months |
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Inclusion Criteria:
Preoperative Inclusion criteria:
Intraoperative inclusion criteria before closure:
Exclusion Criteria:
Preoperative exclusion criteria:
Intraoperative exclusion criteria before closure:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nuh N Rahbari, MD | Contact | +49 6221 56 39448 | nuh.rahbari@med.uni-heidelberg.de | |
| Sabine - Voß, MD | Contact | +49 6221 56 6986 | sabine.voss@med.uni-heidelberg.de |
| Name | Affiliation | Role |
|---|---|---|
| Nuh N Rahbari, MD | Department of Surgery, University of Heidelberg | Study Director |
| Markus W Büchler, MD | Department of Surgery, University of Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery | Recruiting | Heidelberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22647387 | Derived | Rahbari NN, Knebel P, Kieser M, Bruckner T, Bartsch DK, Friess H, Mihaljevic AL, Stern J, Diener MK, Voss S, Rossion I, Buchler MW, Seiler CM. Design and current status of CONTINT: continuous versus interrupted abdominal wall closure after emergency midline laparotomy - a randomized controlled multicenter trial [NCT00544583]. Trials. 2012 May 30;13:72. doi: 10.1186/1745-6215-13-72. |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Continuous sutures | Procedure | Continuous sutures for abdominal fascia closure with PDS II equivalent USP 1, 150 cm loops |
|