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Perioperative Risk Study

NCT02456389 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1456

Last updated 2025-04-04

No results posted yet for this study

Summary

The primary objective of this trial is to determine if perioperative risk stratification and risk-based, protocol-driven management leads to a reduction in the rate of death or serious complications compared to standard perioperative management in patients undergoing elective major cancer surgery.

Conditions

  • Tumors
  • Primary Neoplasm
  • Secondary Neoplasm
  • Surgery

Interventions

OTHER

Preoperative risk stratification

Preoperative risk-prediction tool based on patient demographics/co-morbidity and planned procedure

OTHER

Postoperative risk stratification

Postoperative risk-prediction tool based on intraoperative variables

OTHER

Risk-based, escalating levels of care

Postoperative observation in regular unit vs. telemetry unit vs. stepdown unit vs. ICU

OTHER

Risk-based, escalating levels of monitoring

Varying frequencies of vital signs monitoring Varying use of telemetry, pulse oximetry, and early warning system

OTHER

Risk-based, escalating levels of co-management

Varying use of Hospitalist co-management

OTHER

Standard postoperative care

Routine postoperative care, as medically indicated

Sponsors & Collaborators

  • Fox Chase Cancer Center

    lead OTHER

Principal Investigators

  • Nestor F Esnaola, MD, MPH, MBA · Fox Chase Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2020-06-19
Completion
2025-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02456389 on ClinicalTrials.gov