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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| da Vinci 5 Robotic Surgical System | |||
| da Vinci Xi Robotic Surgical System |
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| Measure | Description | Time Frame |
|---|---|---|
| Textbook Recovery | 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. | From surgery date to 30 days post-operative |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Instrument Tip Forces | Correlative endpoints will be instrument tip forces measured by the Force Feedback Instruments, including average and peak forces, time above 6.5N and overall work (cumulative force over time) for the overall case and for selected operative steps as determined by video segmentation. An exploratory analysis will be performed to test the associated between dV5 system instrument tip forces (average for the case and per tasks) with primary and secondary outcomes. |
Inclusion Criteria:
Exclusion Criteria:
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Participants in this research will include individuals ages 18 years or older who are undergoing robotic-assisted anatomic lung resection (lobectomy or segmentectomy) at The Ohio State University Wexner Medical Center (OSUMC).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The James Cancer Hospital | Recruiting | Columbus | Ohio | 43221 | United States |
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| 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 |
| From robot docking to robot undocking during surgical procedure |