Perioperative Risk Study

NCT02456389 | Active Not Recruiting DMC

• 1 other identifier: SURG-073
• Study Type: interventional
• Target: 1,456
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Probable cancer; Proven cancer; Elective cancer surgery; Postoperative death; Postoperative complications; Healthcare utilization; Quality of life; Adjuvant therapy; Disease-free survival; Overall survival

Outcome Measures

Primary Outcomes (1)

• Rate of death or serious complications (as defined by American College of Surgeons National Surgical Quality Improvement Program [ACS NSQIP])

  30-day postoperative period

Secondary Outcomes (20)

• Rate of death

  30-day postoperative period

• Rate of serious complication (as defined by ACS NSQIP)

  30-day postoperative period

• Rate of serious/grade 3-4 adverse event (as defined by CTCAE)

  30-day postoperative period

• Rate of Clavien-Dindo grade IIIa-V complication (as defined by ACS NSQIP)

  30-day postoperative period

• Rate of Clavien-Dindo grade IIIa-V adverse event (as defined by CTCAE)

  30-day postoperative period

Other Outcomes (9)

• Rate of unplanned return to the operating room

  30-day postoperative period

• Rate of unplanned hospital readmission

  30-day postoperative period

• Rate of hospital readmission

  60-day postoperative period

Study Arms (2)

Standard perioperative management

ACTIVE COMPARATOR

Standard postoperative care

Other: Standard postoperative care

Risk-based, perioperative management

EXPERIMENTAL

Preoperative risk stratification Postoperative risk stratification Risk-based, escalating levels of care Risk-based, escalating levels of monitoring Risk-based, escalating levels of co-management

Other: Preoperative risk stratification; Other: Postoperative risk stratification; Other: Risk-based, escalating levels of care; Other: Risk-based, escalating levels of monitoring; Other: Risk-based, escalating levels of co-management

Interventions

Preoperative risk stratification OTHER

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

Risk-based, perioperative management

Postoperative risk stratification OTHER

Postoperative risk-prediction tool based on intraoperative variables

Risk-based, perioperative management

Risk-based, escalating levels of care OTHER

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

Risk-based, perioperative management

Risk-based, escalating levels of monitoring OTHER

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

Risk-based, perioperative management

Risk-based, escalating levels of co-management OTHER

Varying use of Hospitalist co-management

Risk-based, perioperative management

Standard postoperative care OTHER

Routine postoperative care, as medically indicated

Standard perioperative management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> or = 18 years at diagnosis.
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2, or 3.
• Probable (i.e., clinically suspicious) or histologically/cytologically confirmed, primary or recurrent, malignant neoplasm, malignant neuroendocrine tumor, or carcinoma in situ (any stage).
• Scheduled for curative or palliative major cancer surgery, including:
• Glossectomy
• Pharyngectomy
• Laryngectomy
• Neck dissection
• Esophagectomy
• Lung resection
• Gastrectomy
• Pancreatectomy
• Hepatectomy
• Colectomy
• Proctectomy

You may not qualify if:

• Clinical or tissue diagnosis of benign neuroendocrine tumor, benign neoplasm, neoplasm of uncertain behavior, or neoplasm of unspecified nature.
• Use of systemic chemotherapy and/or radiation therapy \< 14 days prior to First Registration. Palliative radiation therapy is permitted for irradiating small areas of painful bony metastases that cannot be managed adequately using systemic or local analgesics
• Any condition that might interfere with the subject's participation in the study, compliance with study requirements, or in the evaluation of the study results.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis; Postoperative Complications

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nestor F Esnaola, MD, MPH, MBA

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2015
• First Posted: May 28, 2015
• Study Start: August 1, 2014
• Primary Completion: June 19, 2020
• Study Completion: June 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

US (1)