Evaluating the Association of Force Feedback With Outcomes After Lung Resection Using the da Vinci Multiport System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 18 years or older
Undergoing robotic-assisted anatomic lung resection (lobectomy or segmentectomy) at The Ohio State University Wexner Medical Center
Disqualifiers
Age < 18 years old
Subject is pregnant or suspected to be pregnant or breastfeeding
ECOG Performance status > 2
Do not qualify for ERAS protocol
Trial population
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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
270 Participants
are grouped into 2 trial groupsGroup A: da Vinci 5 Robotic Surgical System
Group B: da Vinci Xi Robotic Surgical System
Trial outcomes
Primary outcomes
1
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.
Time frame
From surgery date to 30 days post-operativeSecondary outcomes
1
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 days2
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 days3
Percutaneous drainage/output from chest tube in milliliters (mL)
Time frame
At 24 hours and 48 hours post chest tube insertion4
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 daysOther outcomes
1
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.
Time frame
From robot docking to robot undocking during surgical procedureSponsors and contacts
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Source ClinicalTrials.gov