Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas
NCT ID: NCT05851534
Last Updated: 2024-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2575 participants
INTERVENTIONAL
2024-09-02
2028-09-02
Brief Summary
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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?
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Detailed Description
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Objective To investigate whether implementation of a best practice program for preoperative optimisation of patients with a focus on screening, assessment, and intervention of 8 potentially (partly) modifiable risk factors (low (aerobic) fitness level, malnutrition, low psychological resilience, comorbidities (iron deficiency (anaemia), impaired glucose control and frailty), and intoxications (alcohol and smoking behaviour)) will improve the time to functional recovery.
Study design A nationwide stepped-wedge cluster randomized trial. In this design all participating centres will cross over from current practice to the best practice program, in a randomised order. At the end of the study, all centres will have implemented the best practice program.
Study population 13 centres performing major pancreatic surgery in the Netherlands collaborating within the Dutch Pancreatic Cancer Group (DPCG).
Intervention 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. This program is based on findings in previous screening and prehabilitation programs, a national inventory of current preoperative care protocols and expert opinion. Consensus upon this program was reached with pancreatic surgeons from all centres of the DPCG. The final program was critically reviewed by the advisory committee of internationally respected experts in the field of prehabilitation and pancreatology.
Comparison Preoperative care according to current practice.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Standard care
Receiving standard preoperative care
No interventions assigned to this group
Best practice program
Implementation of best practice preoperative optimisation program
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* acute pancreatic resections (resection scheduled within two weeks)
18 Years
ALL
No
Sponsors
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Rising Tide Foundation
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Marcel den Dulk, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center/ University Maastricht
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Koop Bosscha, MD PhD
Role: primary
Marc Besselink, MD PhD
Role: primary
Tom Karsten, MD PhD
Role: primary
Jennifer Schreinemakers, MD PhD
Role: primary
Ignace de Hingh, MD PhD
Role: primary
Daan Lips, MD PhD
Role: primary
Joost Klaase, MD PhD
Role: primary
Eric Manusama, MD PhD
Role: primary
Sven Mieog, MD PhD
Role: primary
Marcel den Dulk, MD PhD
Role: primary
Kees van Laarhoven, MD PhD
Role: primary
Bas Groot Koerkamp, MD PhD
Role: primary
Hjalmar van Santvoort, MD PhD
Role: primary
Other Identifiers
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2023-3607
Identifier Type: -
Identifier Source: org_study_id
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