MedTrace Logo

Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas

NCT05851534 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2575

Last updated 2024-10-26

No results posted yet for this study

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?

Conditions

  • Prehabilitation
  • Pancreas Cancer
  • Surgery
  • Postoperative Complications

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

Sponsors & Collaborators

  • Rising Tide Foundation

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Marcel den Dulk, MD PhD · Maastricht University Medical Center/ University Maastricht

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-02
Primary Completion
2027-09-02
Completion
2028-09-02

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05851534 on ClinicalTrials.gov