A Prospective Study Frailty for Esophagectomy and Lung Resection in Thoracic Surgery
- Conditions
- Thoracic NeoplasmLung CancerEsophageal CancerSurgeryFrail Elderly SyndromeSurgery--ComplicationsSarcopeniaThoracicMalnutrition
- Interventions
- Diagnostic Test: Frailty model
- Registration Number
- NCT03413449
- Lead Sponsor
- The Cleveland Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
- All patients >18 years old who are undergoing pneumonectomy, lobectomy or esophagectomy with a cancer diagnosis over a 1-year enrollment.
- Patients who are unable to sign a consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Resections Frailty model Frailty model for patients undergoing esophagectomy and pneumonectomy/lobectomy for cancer
- Primary Outcome Measures
Name Time Method Morbidity 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
Discharge status Assessed at discharge and will be reported through study completion, an average of 1 year Discharge destination
- Secondary Outcome Measures
Name Time Method 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 Time spent in the hospital during perioperative stay
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 If a patient requires a readmission to the hospital within 30 days of discharge and the reasons for readmission
Trial Locations
- Locations (1)
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States