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Postoperative Standardization of Care: the Implementation of Best Practice After Pancreatic Resection. A nationwide stepped-wedge cluster randomized trial.


- candidate number28352
- NTR NumberNTR6905
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-dec-2017
- Secondary IDsKWF 2017-8272 
- Public TitlePostoperative Standardization of Care: the Implementation of Best Practice After Pancreatic Resection. A nationwide stepped-wedge cluster randomized trial.
- Scientific TitlePostoperative Standardization of Care: the Implementation of Best Practice After Pancreatic Resection. A nationwide stepped-wedge cluster randomized trial.
- ACRONYMPORSCH
- hypothesisThe hypothesis of this trial is that the implementation of a best practice algorithm for postoperative care focusing on early detection and step-up management of postoperative pancreatic fistula results in a lower rate of major complications and death after pancreatic resection, as compared to current practice.
- Healt Condition(s) or Problem(s) studiedPancreatic cancer, Pancreatic fistula
- Inclusion criteriaCLUSTERS: All centers performing pancreatic surgery in The Netherlands (the DPCG centers) are included in this study.
PATIENTS: Outcomes of all patients undergoing pancreatic resection in The Netherlands in the study period will be evaluated
- Exclusion criteriaNone
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 8-jan-2018
- planned closingdate9-nov-2019
- Target number of participants1600
- InterventionsThis trial evaluates a cluster level intervention in which clinicians involved in the postoperative care for patients undergoing pancreatic resection are informed on the best practice algorithm for early detection and minimally invasive management of postoperative pancreatic fistula.

To evaluate the effect of this intervention in terms of decreasing the risk of major complications and death, outcomes of patients undergoing pancreatic resection before implementation (i.e. current practice) will be compared to outcomes of patients undergoing pancreatic resection after implementation of the algorithm (i.e. best practice).
- Primary outcomeComposite primary endpoint: post-pancreatectomy bleeding, new-onset organ failure or mortality
- Secondary outcomeSecondary endpoints include the individual components of the primary endpoint and other clinical outcomes, healthcare resource utilization, number of patients receiving adjuvant chemotherapy and costs analysis.
- TimepointsFollow-up will be 90 days after pancreatic resection.
- Trial web sitehttp://www.dpcg.nl/projecten/porsch.html
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD candidate F.J (Jasmijn) Smits
- CONTACT for SCIENTIFIC QUERIESDr. Hjalmar C. Santvoort, van
- Sponsor/Initiator St. Antonius Hospital
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- Publications
- Brief summaryRATIONALE
Pancreatic resection is a major abdominal operation with 50% chance of postoperative complications. A feared complication is severe pancreatic fistula, in which there is leakage of enzyme rich fluid into the abdominal cavity. Adequate complication management appears to be the most important factor in improving outcomes of patients undergoing pancreatic resection.

OBJECTIVE
To investigate whether implementation of a best practice algorithm for postoperative care focusing on early detection and step-up management of postoperative pancreatic fistula results in a lower rate of major complications and death after pancreatic resection as compared to current practice

STUDY DESIGN
A nationwide stepped-wedge, cluster randomized, superiority trial. In this design all participating centers cross over from current practice to best practice according to the algorithm, but are randomized to determine the exact order. At the end of the trial, all centers will have implemented the best practice algorithm.

STUDY POPULATION All centers performing pancreatic surgery in the Netherlands (i.e. the Dutch Pancreatic Cancer Group). Outcomes will be evaluated in all patients undergoing pancreatic resection in The Netherlands during the study period.

INTERVENTION Cluster level education on postoperative care according to a best practice algorithm, focusing on early detection and step-up management of postoperative pancreatic fistula. This algorithm is based on findings in Dutch observational cohort studies, systematic literature analyses, an inventory in current protocols on postoperative care and expert opinion. The proposed algorithm is validated in a multicenter cohort and consensus upon this algorithm is reached with pancreatic surgeons from all centers of the Dutch Pancreatic Cancer Group. The final algorithm was reviewed critically by the advisory committee of internationally respected experts in the field of pancreatology before implementation in this trial.

COMPARISON
Postoperative care according to current practice.

ENDPOINTS
The primary outcome was measured in all patients undergoing pancreatic resection and is a composite of major complications (i.e. postpancreatectomy bleeding, newonset organ failure and death). Secondary endpoints include the individual components of the primary endpoint and other clinical outcomes, healthcare resource utilization, adjuvant chemotherapy and costs analysis. Follow-up will be 90 days after pancreatic resection
- Main changes (audit trail)
- RECORD16-dec-2017 - 8-jan-2018


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