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Completed

NCT Number: NCT03293862

Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São, 05403000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

prophylactic polypropilene mesh

Device

Placement of onlay polypropilene prophylactic mesh after midline fascial closure.

Midline Fascial Closure

Procedure

midline fascial closure using uninterrupted PDS 0 suture

vacuum drainage system

Device

Placement of a subcutaneous vacuum drainage system

Primary outcomes

  1. Fascial dehiscence incidence

    Time frame: 30 days

Secondary outcomes

  1. Surgical site occurence (SSO) incidence

    Time frame: 30 days or during hospital stay

  2. Surgical site occurrence requiring procedural intervention (SSOPI) incidence

    Time frame: 30 days or during hospital stay

  3. Operative time (minutes),

    Time frame: 30 days

  4. Hospital length of stay (days)

    Time frame: 30 days

  5. Intensive care unit length of stay (days)

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Sep 26, 2017
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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