Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies (NCT03293862) | Clinical Trial Compass
CompletedNot Applicable
Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies
Brazil145 participantsStarted 2015-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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.