Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05851534

Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas

Led by Maastricht University Medical Center · Updated on 2024-10-26

2575

Participants Needed

13

Research Sites

208 weeks

Total Duration

On this page

Sponsors

M

Maastricht University Medical Center

Lead Sponsor

R

Rising Tide Foundation

Collaborating Sponsor

AI-Summary

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?

CONDITIONS

Official Title

Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients planned for curative treatment, with or without neoadjuvant therapy, scheduled for elective pancreatic resection
  • Surgery planned at one of the Dutch Pancreatic Cancer Group centers performing major pancreatic surgery
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Acute pancreatic resections scheduled within two weeks

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

Jeroen Bosch Hospital

's-Hertogenbosch, Netherlands

Actively Recruiting

2

Amsterdam University Medical Center

Amsterdam, Netherlands

Actively Recruiting

3

OLVG

Amsterdam, Netherlands

Actively Recruiting

4

Amphia Hospital

Breda, Netherlands

Actively Recruiting

5

Catharina Hospital

Eindhoven, Netherlands

Actively Recruiting

6

Medisch Spectrum Twente

Enschede, Netherlands

Actively Recruiting

7

University Medical Center Groningen

Groningen, Netherlands

Actively Recruiting

8

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Actively Recruiting

9

Leiden University Medical Center

Leiden, Netherlands

Actively Recruiting

10

Maatricht University Medical Center

Maastricht, Netherlands, 6202AZ

Actively Recruiting

11

Radboud University Medical Center

Nijmegen, Netherlands

Actively Recruiting

12

Erasmus Medical Center

Rotterdam, Netherlands

Actively Recruiting

13

RAKU

Utrecht, Netherlands

Actively Recruiting

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Research Team

M

Marcel den Dulk, MD PhD

CONTACT

H

Heleen Driessens, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

2

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