RecruitingNot ApplicableNCT05851534

Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas

Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas: the Implementation of Best Practice Before Pancreatic Resection


Sponsor

Maastricht University Medical Center

Enrollment

2,575 participants

Start Date

Sep 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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?


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • 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 Criteria2

  • age \< 18 years
  • acute pancreatic resections (resection scheduled within two weeks)

Interventions

BEHAVIORALPreoperative optimisation program

Preoperative screening of all patients scheduled for pancreatic resection on (aerobic) fitness level, malnutrition risk, psychological resilience, haemoglobin, iron and HbA1c concentration, frailty, and alcohol and smoking behaviour. All patients are provided with a patient-tailored, multimodal prehabilitation program, in which these potentially (partly) modifiable factors are preoperatively addressed


Locations(13)

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

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NCT05851534


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