Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas

Study Overview
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Brief Summary
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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: Does a prehabilitation program improve the time to functional recovery after pancreatic surgery? Does a prehabilitation program lead to a reduction in the Comprehensive Complication Index after pancreatic surgery?

Detailed Description
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Background In the past, little attention has been given in the daily practice to the patient's condition before an operation. Recent studies have shown the benefit of preoperative optimisation programs. However, these studies consisted only of smaller studies and were mainly performed in patients who underwent colorectal surgery. Although promising, unfortunately, strong evidence to support the contribution of prehabilitation to optimize the functional outcome after surgery is still lacking and consequently it is not included in the Dutch basic health insurance package. 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 All 15 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.

Official Title
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Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas: the Implementation of Best Practice Before Pancreatic Resection

Conditions
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Prehabilitation, Pancreas Cancer, Surgery, Postoperative Complications

Intervention / Treatment
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* Behavioral: Preoperative optimisation program


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Stepped-wedge cluster randomized superiority trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>Receiving standard preoperative care | |
| Experimental: Best practice program<br>Implementation of best practice preoperative optimisation program | Behavioral: Preoperative optimisation program<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to functional recovery | Functional recovery is achieved when all of the following five criteria are met: a) restored level of mobility at the preoperative level, b) sufficient pain control with oral medication alone, c) ability to maintain at least 50% daily required protein and energy intake, d) no intravenous fluid administration, and e) no clinical signs of infection. | On average 6-10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehensive Complication Index (CCI) | The CCI is calculated as the sum of all complications that are weighted for their severity, with a range from 0 to 100, whereby a higher score indicates presence of more complications and/or more severe complications. | 30 days postoperative | 
| Length of hospital stay | Length of hospital stay of the primary admission, measured in days | On average 2 weeks postoperative | 
| Readmissions | Readmissions within 30 days after discharge | 30 days after discharge of primary admission | 
| Postoperative complications | Any postoperative complication | During primary admission, on average 14 weeks postoperative | 
| Incremental cost-effectiveness ratio (ICER) | The difference in costs between standard care and best practice care divided by the difference in health benefits, measured in quality-adjusted life years (QALYs). | 1 year postoperative | 
| Evaluation of health status | Reported health status measured with questionnaire EQ-5D-5L | At baseline, 3 months and 12 months postoperative | 
| Evaluation of quality of life for cancer patients | Reported quality of life measured with questionnaire EORTC QLQ-C30 | At baseline, 3 months and 12 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prehabilitation, Pancreas, Preoperative optimisation