Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies

Study Overview
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Brief Summary
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Facial dehiscence elicit high morbidity and mortality. This complication may arise in more than 8.5% of high-risk patients. Addressing risk factors and optimizing surgical technique are guarded as mainstay measures for prevention, but their efficacy is questionable. The aim of this study is to analyze the influence of using a polypropylene onlay prophylactic mesh on the incidence of fascial dehiscence in emergency surgery and associated complications.

Detailed Description
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Fascial dehiscence is associated with high morbidity and mortality rates. It occurs in more than 8.5% of high-risk patients. Current preventive measures described are control of risk factors and optimization of surgical technique. Despite that, the incidence of such complication remained stable in the last decades, highlighting the low efficacy of such measures. Polypropilene onlay mesh has been used to avoid incisional hernias in selected elective patients, and could be useful in the prevention of fascial dehiscence. In emergency situations, especially in contaminated and infected surgical procedures, safety and efficacy of mesh is controversial. In this study the investigators aimed to evaluate the influence of polypropilene prophylactic onlay mesh on the incidence of fascial dehiscence in high-risk patients undergoing midline emergency laparotomy. As secondary outcome, the associated morbidity, including surgical site occurence, will be analyzed. The study design will be a randomized controlled trial.

Official Title
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Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies: a Randomized Clinical Trial

Conditions
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Surgical Wound Dehiscence

Intervention / Treatment
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* Device: prophylactic polypropilene mesh
* Procedure: Midline Fascial Closure
* Device: vacuum drainage system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Emergency laparotomy by midline incision High risk for abdominal wound dehiscence: Risk index** ≥ 4,0 or ≥ 2,2 in combination with at least one of the following: smoking, obesity, malnutrition or malignant neoplasia. Risk index is the sum of values associated with high-risk characteristics, based in the risk score for abdominal wall dehiscence published by van Ramshorst et. al. in World Journal of Surgery, 2010 (Rotterdam risk model): Age category (in years) 40-49: 0.4 50-59: 0.9 60-69: 0.9 ≥70: 1.1 Male gender: 0.7 Chronic pulmonary disease: 0.7 Ascites: 1.5 Jaundice: 0.5 Anemia: 0.7 Emergency surgery: 0.6 Type of surgery: Gallbladder/bile duct 0.7 Esophagus 1.5 Gastroduodenum 1.4 Small bowel 0.9 Large bowel 1.4 Vascular 1.3 Exclusion Criteria: Non-midline incisions or midline laparotomy measuring less than 1/4 the distance between the xyphoid and the pubis, including laparoscopic surgery. Diagnosis of incisional hernia or presence of previous mesh on site. Midline laparotomy performed in less than 30 days. Pregnancy Severe trauma with hemodynamic instability Need for open abdomen or relaxing incisions Need for re-laparotomy during the first 30 postoperative days, except cases in which an abdominal wall dehiscence was diagnosed. Death during the first 30 postoperative days, except cases in which an abdominal wall dehiscence was diagnosed before the event.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Suture group and prophylactic mesh group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suture group<br>Patients randomized to this arm will undergo midline laparotomy closure using a PDS 0 continuous suture only, without mesh, aiming a suture length to wound length ratio higher than four. Randomization occurs after fascial closure. | Procedure: Midline Fascial Closure<br>* midline fascial closure using uninterrupted PDS 0 suture<br>|
| Experimental: Prophylactic mesh group<br>Patients randomized to this arm will undergo midline laparotomy closure using a PDS 0 continuous suture aiming a suture length to wound length ratio higher than four AND further polypropilene onlay mesh. Randomization occurs after fascial closure. | Device: prophylactic polypropilene mesh<br>* Placement of onlay polypropilene prophylactic mesh after midline fascial closure.<br>Procedure: Midline Fascial Closure<br>* midline fascial closure using uninterrupted PDS 0 suture<br>Device: vacuum drainage system<br>* Placement of a subcutaneous vacuum drainage system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fascial dehiscence incidence |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site occurence (SSO) incidence |  | 30 days or during hospital stay | 
| Surgical site occurrence requiring procedural intervention (SSOPI) incidence |  | 30 days or during hospital stay | 
| Operative time (minutes), |  | 30 days | 
| Hospital length of stay (days) |  | 30 days | 
| Intensive care unit length of stay (days) |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emergency surgery, laparotomy, abdominal wound dehiscence, prophylactic mesh