Clinical trial NCT03293862: Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies
Official title: Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Dehiscence
Keywords: laparotomy
emergency surgery
abdominal wound dehiscence
prophylactic mesh
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Suture group and prophylactic mesh group
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fascial dehiscence incidence
timeFrame: 30 days
Secondary outcomes:
measure: Surgical site occurence (SSO) incidence
timeFrame: 30 days or during hospital stay
measure: Surgical site occurrence requiring procedural intervention (SSOPI) incidence
timeFrame: 30 days or during hospital stay
measure: Operative time (minutes),
timeFrame: 30 days
measure: Hospital length of stay (days)
timeFrame: 30 days
measure: Intensive care unit length of stay (days)
timeFrame: 30 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
state: São
Study officials:
References:
citation: Gomez Diaz CJ, Rebasa Cladera P, Navarro Soto S, Hidalgo Rosas JM, Luna Aufroy A, Montmany Vioque S, Corredera Cantarin C. [Validation of abdominal wound dehiscence's risk model]. Cir Esp. 2014 Feb;92(2):114-9. doi: 10.1016/j.ciresp.2012.12.008. Epub 2013 May 3. Spanish.
citation: van Ramshorst GH, Nieuwenhuizen J, Hop WC, Arends P, Boom J, Jeekel J, Lange JF. Abdominal wound dehiscence in adults: development and validation of a risk model. World J Surg. 2010 Jan;34(1):20-7. doi: 10.1007/s00268-009-0277-y.
citation: Lima HVG, Rasslan R, Novo FCF, Lima TMA, Damous SHB, Bernini CO, Montero EFS, Utiyama EM. Prevention of Fascial Dehiscence with Onlay Prophylactic Mesh in Emergency Laparotomy: A Randomized Clinical Trial. J Am Coll Surg. 2020 Jan;230(1):76-87. doi: 10.1016/j.jamcollsurg.2019.09.010. Epub 2019 Oct 28.