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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Diagnostic Test: Frailty model


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Resections<br>Frailty model for patients undergoing esophagectomy and pneumonectomy/lobectomy for cancer | Diagnostic Test: Frailty model<br>* Grip strength 30 second chair sit stand test Psoas muscle area Six minute walk<br>|

What is the study measuring?
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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 |