Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas
Recruiting · NCT05851534 · Interventional (participants receive a specific treatment) · Lead sponsor: Maastricht University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this stepped-wedge randomized controlled trial is to investigate whether implementation of a best practice program for preoperative optimisation (prehabilitation program) with a focus on screening, assessment, and intervention of 8 potentially (partly) modifiable risk factors in patients with (suspected) pancreatic cancer will improve outcome. The main questions it will aim to answer are: 1. Does a prehabilitation program improve the time to functional recovery after pancreatic surgery? 2. Does a prehabilitation program lead to a reduction in the Comprehensive Complication Index after pancreatic surgery?
Who can take part
Inclusion criteria
- All patients who are planned for a curative treatment with or without neoadjuvant treatment and elective pancreatic resection in one of the centres of the Dutch Pancreatic Cancer Group (i.e. all centres performing major pancreatic surgery)
Exclusion criteria
- age \< 18 years
- acute pancreatic resections (resection scheduled within two weeks)
Where it is running
13 locations listed.
- Jeroen Bosch Hospital - 's-Hertogenbosch, Netherlands
- Amsterdam University Medical Center - Amsterdam, Netherlands
- OLVG - Amsterdam, Netherlands
- Amphia Hospital - Breda, Netherlands
- Catharina Hospital - Eindhoven, Netherlands
- Medisch Spectrum Twente - Enschede, Netherlands
- University Medical Center Groningen - Groningen, Netherlands
- Medisch Centrum Leeuwarden - Leeuwarden, Netherlands
- Leiden University Medical Center - Leiden, Netherlands
- Maatricht University Medical Center - Maastricht, Netherlands
- Radboud University Medical Center - Nijmegen, Netherlands
- Erasmus Medical Center - Rotterdam, Netherlands
- RAKU - Utrecht, Netherlands