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

Plain Language Summary

Simplified for easier understanding

This trial looks at how optimizing health before pancreatic cancer surgery can improve patient outcomes and recovery. You may be eligible if... - You are scheduled for planned (elective) pancreatic surgery as part of curative treatment at a Dutch Pancreatic Cancer Group center - Your surgery may be with or without neoadjuvant (pre-surgery) treatment You may NOT be eligible if... - You are under 18 years old - Your pancreatic surgery is urgent and scheduled within two weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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