Evaluating the Association of Force Feedback With Outcomes After Lung Resection Using the da Vinci Multiport System
16. juni 2026 opdateret af: Peter Kneuertz, Ohio State University
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.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
270
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ohio
-
Columbus, Ohio, Forenede Stater, 43221
- Rekruttering
- The James Cancer Hospital
-
Ledende efterforsker:
- Peter Kneuertz, MD
-
Kontakt:
- Chandler Lowe
- Telefonnummer: 614-293-9955
- E-mail: chandler.lowe@osumc.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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).
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
da Vinci 5 Robotic Surgical System
|
|
da Vinci Xi Robotic Surgical System
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Textbook Recovery
Tidsramme: 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.
|
From surgery date to 30 days post-operative
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Total Opioid Consumption
Tidsramme: 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 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
Tidsramme: 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 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)
Tidsramme: At 24 hours and 48 hours post chest tube insertion
|
At 24 hours and 48 hours post chest tube insertion
|
|
Length of Chest Tube Duration
Tidsramme: 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 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Instrument Tip Forces
Tidsramme: From robot docking to robot undocking during surgical procedure
|
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.
|
From robot docking to robot undocking during surgical procedure
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
5. september 2025
Primær færdiggørelse (Anslået)
30. juni 2027
Studieafslutning (Anslået)
31. december 2027
Datoer for studieregistrering
Først indsendt
2. marts 2026
Først indsendt, der opfyldte QC-kriterier
16. juni 2026
Først opslået (Faktiske)
22. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juni 2026
Sidst verificeret
1. marts 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- STUDY20250072
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