The PRECious protocol is a stepped-wedge trial designed to evaluate whether standardized postoperative CRP measurement followed by CT imaging for levels exceeding 140 mg/L reduces morbidity and mortality after major abdominal surgery.
RCT (n=1,050)
Open-label
Stepped-wedge
Yes
Does a standardized postoperative quality control algorithm using routine CRP measurement followed by CT scanning reduce morbidity and mortality in adult patients undergoing elective major abdominal surgery?
The PRECious trial protocol outlines a stepped-wedge study to determine if routine postoperative CRP monitoring followed by targeted CT scanning improves clinical outcomes and cost-effectiveness after major abdominal surgery.
BACKGROUND: After major abdominal surgery (MAS), 20% of patients endure major complications, which require invasive treatment and are associated with increased morbidity and mortality. A quality control algorithm after major abdominal surgery aimed at early identification of patients at risk of developing major complications can decrease associated morbidity and mortality. Literature studies show promising results for C-reactive protein (CRP) as an early marker for postoperative complications, however clinical significance has yet to be determined. METHODS: A multicenter, stepped wedge, prospective clinical trial including all adult patients planned to undergo elective MAS. The first period consists of standard postoperative monitoring, which entails on demand additional examinations. This is followed by a period with implementation of postoperative control according to the PRECious protocol, which implicates standardized measurement of CRP levels. If CRP levels exceed 140 mg/L on postoperative day 3,4 or 5, an enhanced CT-scan is performed. Primary outcome in this study is a combined primary outcome, entailing all morbidity and mortality due to postoperative complications. Complications are graded according to the Clavien-Dindo classification. Secondary outcomes are hospital length of stay, patients reported outcome measures (PROMs) and cost-effectiveness. Data will be collected during admission, three months and one year postoperatively. Approval by the medical ethics committee of the VU University Medical Center was obtained (ID 2015.114). DISCUSSION: the PRECious trial is a stepped-wedge, multicenter, open label, prospective clinical trial to determine the effect of a standardized postoperative quality control algorithm on postoperative morbidity and mortality, and cost-effectiveness. TRIAL REGISTRATION: www.ClinicalTrials.gov, NCT02102217. Registered 5 February 2015.
Straatman et al. (Thu,) conducted a rct in Major abdominal surgery (n=1,050). PRECious protocol (standardized CRP measurement on POD 3-5, CT if >140 mg/L) vs. Standard postoperative monitoring (on-demand examinations) was evaluated on Combined morbidity and mortality due to major complications (Clavien-Dindo grades III, IV and V). The PRECious protocol is a stepped-wedge trial designed to evaluate whether standardized postoperative CRP measurement followed by CT imaging for levels exceeding 140 mg/L reduces morbidity and mortality after major abdominal surgery.