Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies
1 other identifier
interventional
145
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 20, 2017
CompletedFirst Posted
Study publicly available on registry
September 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedApril 17, 2019
April 1, 2019
1.8 years
September 20, 2017
April 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fascial dehiscence incidence
30 days
Secondary Outcomes (5)
Surgical site occurence (SSO) incidence
30 days or during hospital stay
Surgical site occurrence requiring procedural intervention (SSOPI) incidence
30 days or during hospital stay
Operative time (minutes),
30 days
Hospital length of stay (days)
30 days
Intensive care unit length of stay (days)
30 days
Study Arms (2)
Suture group
ACTIVE COMPARATORPatients 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.
Prophylactic mesh group
EXPERIMENTALPatients 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.
Interventions
Placement of onlay polypropilene prophylactic mesh after midline fascial closure.
midline fascial closure using uninterrupted PDS 0 suture
Placement of a subcutaneous vacuum drainage system
Eligibility Criteria
You may qualify if:
- 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)
- : 0.4
- : 0.9
- : 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:
- +6 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São, 05403000, Brazil
Related Publications (3)
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.
PMID: 23648044BACKGROUNDvan 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.
PMID: 19898894RESULTLima 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.
PMID: 31672681DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Full Professor of Surgery
Study Record Dates
First Submitted
September 20, 2017
First Posted
September 26, 2017
Study Start
June 1, 2015
Primary Completion
March 1, 2017
Study Completion
February 1, 2018
Last Updated
April 17, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share