Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies

University of Sao Paulo General Hospital

Status: Completed

Conditions: Surgical Wound Dehiscence

Treatments: Device: prophylactic polypropilene mesh; Procedure: Midline Fascial Closure; Device: vacuum drainage system

Study type: Interventional

Funder types: Other

Identifiers

NCT03293862

2024878

Details and patient eligibility

About

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.

Full 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.

Enrollment: 145 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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145 participants in 2 patient groups

Suture group

Active Comparator group

Description:

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.

Treatment:

Procedure: Midline Fascial Closure

Prophylactic mesh group

Experimental group

Description:

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.

Treatment:

Device: vacuum drainage system

Device: prophylactic polypropilene mesh

Procedure: Midline Fascial Closure