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

NCT03413449 | Completed

• 1 other identifier: 17-1708
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• Discharge status

  Discharge destination

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

Secondary Outcomes (2)

• Length of stay

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

• 30 day readmission

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

Study Arms (1)

Resections

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

Diagnostic Test: Frailty model

Interventions

Frailty model DIAGNOSTIC_TEST

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

Resections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All patients \>18 years old who are undergoing pneumonectomy, lobectomy or esophagectomy with a cancer diagnosis over a 1-year enrollment.

You may not qualify if:

• Patients who are unable to sign a consent.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Thoracic Neoplasms; Lung Neoplasms; Esophageal Neoplasms; Sarcopenia; Malnutrition

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Respiratory Tract Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Sudish Murthy, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: January 29, 2018
• Study Start: January 8, 2018
• Primary Completion: June 22, 2021
• Study Completion: November 8, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)