Evaluating the Association of Force Feedback With Outcomes After Lung Resection Using the da Vinci Multiport System
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lobectomy, Segmentectomy, Force Measurement. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Textbook Recovery [Time frame: From surgery date to 30 days post-operative]
Secondary outcome measures (4)
- Total Opioid Consumption [Time frame: 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 [Time frame: 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) [Time frame: At 24 hours and 48 hours post chest tube insertion]
- Length of Chest Tube Duration [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- The James Cancer Hospital — Columbus
Identifiers
NCT: NCT07660900 · STUDY20250072