Evaluating the Association of Force Feedback With Outcomes After Lung Resection Using the da Vinci Multiport System
16. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Antatt)
270
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Ohio
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Columbus, Ohio, Forente stater, 43221
- Rekruttering
- The James Cancer Hospital
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Hovedetterforsker:
- Peter Kneuertz, MD
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Ta kontakt med:
- Chandler Lowe
- Telefonnummer: 614-293-9955
- E-post: Chandler.Lowe@osumc.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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da Vinci 5 Robotic Surgical System
|
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da Vinci Xi Robotic Surgical System
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
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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
|
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Percutaneous drainage/output from chest tube in milliliters (mL)
Tidsramme: At 24 hours and 48 hours post chest tube insertion
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At 24 hours and 48 hours post chest tube insertion
|
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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
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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 |
Tiltaksbeskrivelse |
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.
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From robot docking to robot undocking during surgical procedure
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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
5. september 2025
Primær fullføring (Antatt)
30. juni 2027
Studiet fullført (Antatt)
31. desember 2027
Datoer for studieregistrering
Først innsendt
2. mars 2026
Først innsendt som oppfylte QC-kriteriene
16. juni 2026
Først lagt ut (Faktiske)
22. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. juni 2026
Sist bekreftet
1. mars 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- STUDY20250072
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