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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03413449
• Other study ID #: 17-1708
• Status: Active, not recruiting
• Start date: January 8, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: December 31, 2024
• Est. primary completion date: June 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Dissection
• Esophageal Cancer
• Frail Elderly Syndrome
• Frailty
• Lung Cancer
• Malnutrition
• Sarcopenia
• Surgery
• Surgery--Complications
• Thoracic
• Thoracic Neoplasm
• Thoracic Neoplasms

Intervention

Diagnostic Test:
• Frailty model
Grip strength 30 second chair sit stand test Psoas muscle area Six minute walk

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Discharge status	Discharge destination	Assessed at discharge and will be reported through study completion, an average of 1 year
Secondary	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
Secondary	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