PReoperative Optimisation of Modifiable rIsk factorS in surgEry of the Pancreas: the implementation of best practice before pancreatic resectio
- Conditions
- disease of the pancreasPancreatic tumour100179341001799110024450
- Registration Number
- NL-OMON56511
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 2575
Inclusion Criteria
-Patients scheduled to undergo pancreatic resection in one of the 13
participating DPCG centers in the Netherlands (including for (pre)malignant or
benign lesions and chronic pancreatitis) or the intention to undergo pancreatic
resection after neoadjuvant treatment (for malignant tumours)
- Understanding of and being able to read the Dutch language
Exclusion Criteria
- Age < 18 years
- Being legally incapable
- Undergoing an acute pancreatic resection (resection scheduled within two
weeks)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is time to functional recovery after surgery, which is<br /><br>achieved when all of the following five criteria are met: a) restored level of<br /><br>mobility to the level of independence (or to the preoperative level in case<br /><br>mobility was preoperatively already impaired), b) sufficient pain control with<br /><br>oral medication alone, c) ability to maintain at least 50% daily required<br /><br>protein and energy intake, d) no intravenous fluid administration, and e) no<br /><br>clinical signs of infection (CRP < 150 mg/L and temperature < 38.5 degrees<br /><br>Celsius).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The most relevant secondary outcomes are the Comprehensive Complication Index<br /><br>(CCI), complications graded by Clavien-Dindo classification, length of hospital<br /><br>stay, readmission rate, quality of life and (cost) effectiveness. </p><br>