Clinical trial NCT03413449: A Prospective Study Frailty for Esophagectomy and Lung Resection in Thoracic Surgery
Official title: A Prospective Study Frailty for Esophagectomy and Lung Resection in Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic
Thoracic Neoplasm
Lung Cancer
Esophageal Cancer
Surgery--Complications
Surgery
Sarcopenia
Malnutrition
Frail Elderly Syndrome
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are diagnosed with esophageal or lung cancer and are referred for surgery are included.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Morbidity
timeFrame: Assessed at discharge and will be reported through study completion, an average of 1 year
measure: Discharge status
timeFrame: Assessed at discharge and will be reported through study completion, an average of 1 year
Secondary outcomes:
measure: Length of stay
timeFrame: Assessed from date of surgery until the date of discharge and will be reported through study completion, an average of 1 year
measure: 30 day readmission
timeFrame: Assessed from date of discharge to thirty days after discharge and will be reported through study completion, an average of 1 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Sudish Murthy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: