A Prospective Study Frailty for Esophagectomy and Lung Resection in Thoracic Surgery

The purpose of this study is to develop an all-encompassing frailty model using laboratory and functional studies. A frailty model will help us determine prior to surgery who will require rehabilitation and skilled nursing needs beyond discharge. This model will also help us determine who will likely be readmitted and why they will be readmitted. Understanding these things can help us prevent some of them from occurring in the future.

Study Overview

• Status: Completed
• Conditions: Malnutrition; Esophageal Cancer; Lung Cancer; Frail Elderly Syndrome; Sarcopenia; Surgery; Surgery--Complications; Thoracic Neoplasm; Thoracic
• Intervention / Treatment: Diagnostic test: Frailty model

Detailed Description

Frailty is a widely accepted but poorly defined physical condition that has been shown to be an independent predictor of surgical morbidity and direct discharge to skilled nursing facility (SNF). Attempts have been made to study frailty in surgical patients by employing models designed for the general population. Despite the attempts of studying frailty in general surgery patients, no study has designed a model comprised of objective metrics for general thoracic surgery patients.

The purpose of this study is to better understand frailty in the context of thoracic surgery patients and to develop an objective model of this nebulous variable. It is hoped that standard, simple, functional and laboratory data can be used to construct the model with the goal being to determine the impact of frailty on outcome for patients undergoing esophagectomy, lobectomy, or pneumonectomy. If a preoperative frailty index can be developed and demonstrated to predict outcome, this scoring system may allow care teams to predict post-operative complications, ICU and hospital recidivism, and early mortality, and possibly allow for much earlier preparation for unfavorable outcomes.

• Study Type: Observational
• Enrollment (Actual): 360

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are diagnosed with esophageal or lung cancer and are referred for surgery are included.

Description

Inclusion Criteria:

• All patients >18 years old who are undergoing pneumonectomy, lobectomy or esophagectomy with a cancer diagnosis over a 1-year enrollment.

Exclusion Criteria:

• Patients who are unable to sign a consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Resections; Frailty model for patients undergoing esophagectomy and pneumonectomy/lobectomy for cancer	Diagnostic test: Frailty model; Grip strength; 30 second chair sit stand test; Psoas muscle area; Six minute walk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	Number of STS defined complications (chest tube airleak, atelectasis, pleural effusion requiring drain, pneumonia, ARDS, respiratory failure, bronchopleural fistula, PE, pneumothorax, chylothorax, ventilator > 48 hours, tracheostomy, tracheobronchial injury, ileus, anastomotic leak, GI dilation, conduit necrosis requiring surgery, delayed conduit emptying, C. diff, delirium) will be combined to report the number of morbidity events	Assessed at discharge and will be reported through study completion, an average of 1 year
Discharge status	Discharge destination	Assessed at discharge and will be reported through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Time spent in the hospital during perioperative stay	Assessed from date of surgery until the date of discharge and will be reported through study completion, an average of 1 year
30 day readmission	If a patient requires a readmission to the hospital within 30 days of discharge and the reasons for readmission	Assessed from date of discharge to thirty days after discharge and will be reported through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Sudish Murthy, MD, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Actual): June 22, 2021
• Study Completion (Actual): November 8, 2024

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Neurologic Manifestations; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neuromuscular Manifestations; Pathologic Processes; Nutrition Disorders; Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Aortic Diseases; Muscular Atrophy; Atrophy; Aneurysm; Frailty; Malnutrition; Sarcopenia; Aortic Dissection; Thoracic Neoplasms
• Other Study ID Numbers: 17-1708

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No