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Completed

NCT Number: NCT03413449

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

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.

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Key information

Conditions

Thoracic Atrophy Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Frail Elderly Syndrome Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Malnutrition Muscular Atrophy Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcopenia Signs and Symptoms Surgery Surgery--Complications Thoracic Neoplasm Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Frailty model

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

Primary outcomes

  1. Morbidity

    Time frame: Assessed at discharge and will be reported through study completion, an average of 1 year

    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

  2. Discharge status

    Time frame: Assessed at discharge and will be reported through study completion, an average of 1 year

    Discharge destination

Secondary outcomes

  1. Length of stay

    Time frame: Assessed from date of surgery until the date of discharge and will be reported through study completion, an average of 1 year

    Time spent in the hospital during perioperative stay

  2. 30 day readmission

    Time frame: Assessed from date of discharge to thirty days after discharge and will be reported through study completion, an average of 1 year

    If a patient requires a readmission to the hospital within 30 days of discharge and the reasons for readmission

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2024
First posted
Jan 29, 2018
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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