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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03413449
Enrollment
360
Registered
2018-01-29
Start date
2018-01-08
Completion date
2024-11-08
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTFrailty model

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

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
MorbidityAssessed at discharge and will be reported through study completion, an average of 1 yearNumber 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
Discharge statusAssessed at discharge and will be reported through study completion, an average of 1 yearDischarge destination

Secondary

MeasureTime frameDescription
Length of stayAssessed from date of surgery until the date of discharge and will be reported through study completion, an average of 1 yearTime spent in the hospital during perioperative stay
30 day readmissionAssessed from date of discharge to thirty days after discharge and will be reported through study completion, an average of 1 yearIf a patient requires a readmission to the hospital within 30 days of discharge and the reasons for readmission

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026