Clinical Trial

Preoperative Optimisation of Modifiable Risk Factors in Surgery of the Pancreas

Study acronym: PROMISE-P
Recruiting
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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?
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-05-01; most recent amendment 2024-10-23.
Status change: Not Yet Recruiting → Recruiting 2024-10-23
Trial Details
NCT Number NCT05851534
Lead Sponsor Maastricht University Medical Center
Collaborators: Rising Tide Foundation
Conditions Prehabilitation, Pancreas Cancer, Surgery, Postoperative Complications
Enrollment 2,575 participants
Start Date 2024-09-02
Primary Completion 2027-09-02 (estimated)
Study Completion 2028-09-02 (estimated)
Updated on ClinicalTrials.gov 2024-10-26