Status:
COMPLETED
Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Surgical Wound Dehiscence
Eligibility:
All Genders
18+ years
Phase:
NA
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 mai...
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 optim...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT03293862
Start Date
June 1 2015
End Date
February 1 2018
Last Update
April 17 2019
Active Locations (1)
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1
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São, Brazil, 05403000