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RECRUITING
NCT05851534
NA

Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas

Sponsor: Maastricht University Medical Center

View on ClinicalTrials.gov

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?

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2575

Start Date

2024-09-02

Completion Date

2028-09-02

Last Updated

2024-10-26

Healthy Volunteers

No

Interventions

BEHAVIORAL

Preoperative 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