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

• ClinicalTrials.gov Identifier: NCT03413449
• Recruitment Status: Active, not recruiting
• First Posted: January 29, 2018
• Last Update Posted: October 1, 2021
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): Sudish Murthy, The Cleveland Clinic

Study Description

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.

Condition or disease	Intervention/treatment
Thoracic; Thoracic Neoplasm; Lung Cancer; Esophageal Cancer; Surgery--Complications; Surgery; Sarcopenia; Malnutrition; Frail Elderly Syndrome	Diagnostic Test: Frailty model

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 360 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Study Frailty for Esophagectomy and Lung Resection in Thoracic Surgery
• Actual Study Start Date: January 8, 2018
• Actual Primary Completion Date: July 2, 2019
• Estimated Study Completion Date: July 2, 2023

Groups and Cohorts

Group/Cohort	Intervention/treatment
Resections; Frailty model for patients undergoing esophagectomy and pneumonectomy/lobectomy for cancer	Diagnostic Test: Frailty model; Grip strength; 30 second chair sit stand test; Psoas muscle area; Six minute walk

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients who are diagnosed with esophageal or lung cancer and are referred for surgery are included.

Criteria

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.

Contacts and Locations

Locations

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators

• Principal Investigator: Sudish Murthy, MD, PhD; The Cleveland Clinic

More Information

• Responsible Party: Sudish Murthy, Principal Investigator, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT03413449
• Other Study ID Numbers: 17-1708
• First Posted: January 29, 2018
• Last Update Posted: October 1, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Thoracic Neoplasms; Sarcopenia; Aneurysm, Dissecting; Malnutrition; Frailty; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Neoplasms by Site; Neoplasms; Nutrition Disorders; Pathologic Processes; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical