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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20342

Enrollment

1600

Registered

2017-12-16

Start date

2018-01-08

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer, postoperative pancreatic fistula, pancreasfistel, alvleesklierkanker

Interventions

This 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 ea

Eligibility

Inclusion criteria

Inclusion criteria: CLUSTERS: 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 criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Composite primary endpoint: post-pancreatectomy bleeding, new-onset organ failure or mortality	—

Secondary

Measure	Time frame
Secondary 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.	—

Contacts

Public ContactF.J (Jasmijn) Smits

Dutch Pancreatic Cancer Group, UMC Utrecht, room number E.02.567, internal mail G04.228

f.j.smits@umcutrecht.nl+31 88 75 712 07

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)