APPEAL-studyAnalysis of Predictive Parameters for Evident Anastomotic LeakageA Multicenter Cohort Study
Recruiting
- Conditions
- Anastomotic leakage, colorectal surgery, drainage fluid, biomarkersNaadlekkage, colorectale chirurgie, drainvocht
- Registration Number
- NL-OMON29099
- Lead Sponsor
- Erasmus MC, Rotterdam, The Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 273
Inclusion Criteria
1. All patients in which a drain has been
placed at the anastomotic site after one
of the following procedures:
Exclusion Criteria
1. Pregnancy
2. Age < 18 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure of the APPEAL-study is anastomotic leakage, defined as an insufficiency of the anastomosis, demonstrated by either endoscopy, radiologic studies or operation and leading to a clinical state that requires an intervention. These interventions are:<br /><br> a) Therapeutic drainage<br /><br> b) Use of therapeutic antibiotics<br /><br> c) Any surgical intervention, for example:<br /><br> • Construction diverting stoma<br /><br> • Construction new anastomosis<br /><br> • Surgical disconnection of the <br> anastomosis<br /><br> • Suturing<br /><br><br>
- Secondary Outcome Measures
Name Time Method Comparison of the studied potential biomarkers in terms of speed, accuracy and cost-effectiveness<br>Study the capacity of the potential biomarkers to distinguish between clinically manifest and subclinical anastomotic leakage<br>
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular biomarkers in drainage fluid predict anastomotic leakage in colorectal surgery according to the APPEAL-study (NL-OMON29099)?
How does the APPEAL-study's predictive model for anastomotic leakage compare to standard-of-care risk stratification in colorectal surgery?
Which inflammatory markers (e.g., CRP, IL-6) are evaluated in the NL-OMON29099 multicenter cohort study for anastomotic leakage risk assessment?
What adverse event management protocols are associated with anastomotic leakage detection in the APPEAL-study's colorectal surgery cohort?
Are there competing diagnostic approaches or biomarker panels for predicting anastomotic leakage in colorectal surgery beyond the APPEAL-study's methodology?