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2024-09-02
2027-09-02
2028-09-02
2575
NCT05851534
Maastricht University Medical Center
Maastricht University Medical Center
INTERVENTIONAL
Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas
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?
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 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-04-14 | N/A | 2024-10-23 |
2023-05-01 | N/A | 2024-10-26 |
2023-05-09 | N/A | 2024-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Prevention
Allocation:
Randomized
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| NO_INTERVENTION: Standard care Receiving standard preoperative care | |
| EXPERIMENTAL: Best practice program Implementation of best practice preoperative optimisation program | BEHAVIORAL: Preoperative optimisation program
|
| Primary Outcome Measures | 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 energy intake, d) no intravenous fluid administration, and e) no clinical signs of infection. | On average 6-10 days |
| Secondary Outcome Measures | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Marcel den Dulk, MD PhD Phone Number: +3143 3875492 Email: marcel.den.dulk@mumc.nl |
Study Contact Backup Name: Heleen Driessens, MD Phone Number: +316 83058108 Email: h.driessens@umcg.nl |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
