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

NeuroTherapia, Inc.

Status: Completed

Conditions: Thoracic; Thoracic Neoplasm; Malnutrition; Esophageal Cancer; Surgery; Surgery--Complications; Lung Cancer; Sarcopenia; Frail Elderly Syndrome

Treatments: Diagnostic Test: Frailty model

Study type: Observational

Funder types: Other

Identifiers

NCT03413449

17-1708

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

360 participants in 1 patient group

Resections

Description:

Frailty model for patients undergoing esophagectomy and pneumonectomy/lobectomy for cancer

Treatment:

Diagnostic Test: Frailty model