Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05851534
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2023-04-14
Brief Title:
Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas the Implementation of Best Practice Before Pancreatic Resection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMISE-P
Brief 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
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
Detailed Description:
Background In the past little attention has been given in the daily practice to the patients 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None