Force Measurement, Lobectomy, Segmentectomy
Conditions
Brief summary
The purpose of this research is to study patient outcomes based on the use of Force Feedback instruments during robotic-assisted lung resection. Force Feedback technology describes the physical forces a surgeon senses when pushing and pulling structures inside the body during robotic-assisted surgery.
Detailed description
The objective of the proposed study is to evaluate whether reduced force applied at the tips of Force Feedback instruments is associated with improvements in outcomes following robotic-assisted anatomic lung resections. The investigators propose a prospective cohort study of patients undergoing anatomic lung resection at a single high volume thoracic surgery institution to analyze outcomes based on the use of Force Feedback instruments. Investigators will use a composite endpoint of textbook recovery to capture patients who have an uncomplicated postsurgical trajectory with absence of complication, early discharge, and absence of readmission. The insights gained from this study will help surgeons understand the implications of force applied during thoracic surgical procedures and establishing the value of Force Feedback instruments. The investigators hypothesize that the use of Force Feedback instruments will result in an increase in the rate of early hospital discharge (length of stay less than 3 days) in patients undergoing robotic-assisted anatomic lung resections.
Interventions
None listed
Sponsors
Ohio State University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ages 18 years or older * Undergoing robotic-assisted anatomic lung resection (lobectomy or segmentectomy) at The Ohio State University Wexner Medical Center
Exclusion criteria
* Age \< 18 years old * Subject is pregnant or suspected to be pregnant or breastfeeding * ECOG Performance status \> 2 * Do not qualify for ERAS protocol * Undergoing an emergent procedure * Undergoing non-anatomic lung resection * Undergoing pneumonectomy * Previous ipsilateral thoracic surgery (open, video-assisted thoracoscopic or robotic) * Planned to undergo major concomitant surgery for the treatment of a different medical condition than was originally planned * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Textbook Recovery | From surgery date to 30 days post-operative | The primary endpoint will be the textbook recovery, which will be defined as chest tube removal within 48 hours post-surgery, based on absence of air leak, absence of major complications or mortality within 30 days, no chest tube reinsertion, no atrial fibrillation, early hospital discharge with length of stay \<3 days, and absence of readmission. The rates of textbook recovery will be compared between patients undergoing anatomic lung resection with or without Force Feedback instruments. |
Secondary
| Measure | Time frame |
|---|---|
| Total Opioid Consumption | From admission to the hospital for robotic-assisted anatomic lung resection (lobectomy or segmentectomy) to discharge from the hospital, an average of 2 to 4 days |
| Post-Operative Pain Scores | From admission to the hospital for robotic-assisted anatomic lung resection (lobectomy or segmentectomy) to discharge from the hospital, an average of 2 to 4 days |
| Percutaneous drainage/output from chest tube in milliliters (mL) | At 24 hours and 48 hours post chest tube insertion |
| Length of Chest Tube Duration | From admission to the hospital for robotic-assisted anatomic lung resection (lobectomy or segmentectomy) to discharge from the hospital, an average of 2 to 4 days |
Countries
United States
Outcome results
None listed