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

NCT ID: NCT03413449

Last Updated: 2024-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-08

Study Completion Date

2024-11-08

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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Resections

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

Frailty model

Intervention Type DIAGNOSTIC_TEST

1. Grip strength
2. 30 second chair sit stand test
3. Psoas muscle area
4. Six minute walk

Interventions

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Frailty model

1. Grip strength
2. 30 second chair sit stand test
3. Psoas muscle area
4. Six minute walk

Intervention Type DIAGNOSTIC_TEST

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sudish Murthy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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17-1708

Identifier Type: -

Identifier Source: org_study_id

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