Trial0

Clinical trial · NCT05851534 · RECRUITING · NA

Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas

Sponsor: Maastricht University Medical Center

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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?

Interventions

  • Preoperative optimisation program · BEHAVIORAL

    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

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* 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 Criteria:

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

Sites (13)

  • Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands · RECRUITING
  • Amsterdam University Medical Center, Amsterdam, Netherlands · RECRUITING
  • OLVG, Amsterdam, Netherlands · RECRUITING
  • Amphia Hospital, Breda, Netherlands · RECRUITING
  • Catharina Hospital, Eindhoven, Netherlands · RECRUITING
  • Medisch Spectrum Twente, Enschede, Netherlands · RECRUITING
  • University Medical Center Groningen, Groningen, Netherlands · RECRUITING
  • Medisch Centrum Leeuwarden, Leeuwarden, Netherlands · RECRUITING
  • Leiden University Medical Center, Leiden, Netherlands · RECRUITING
  • Maatricht University Medical Center, Maastricht, Netherlands · RECRUITING
  • Radboud University Medical Center, Nijmegen, Netherlands · RECRUITING
  • Erasmus Medical Center, Rotterdam, Netherlands · RECRUITING
  • RAKU, Utrecht, Netherlands · RECRUITING

Not medical advice. Trial0 is a navigation service, not a medical provider. Nothing here is medical advice or a recommendation to pursue any treatment; eligibility matching is informational, based on published registry criteria, and only the trial site or treating clinician can determine actual eligibility. Decisions belong with the patient and their own doctors. Registry data refreshed at most hourly; last update posted 2024-10-26.