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Evaluating the Association of Force Feedback With Outcomes After Lung Resection Using the da Vinci Multiport System

2026年6月16日 更新者：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.

研究概览

地位

招聘中

条件

详细说明

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.

研究类型

观察性的

注册 (估计的)

270

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Ohio
      • Columbus、Ohio、美国、43221
        • 招聘中
        • The James Cancer Hospital
        • 首席研究员：
          • Peter Kneuertz, MD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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).

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
da Vinci 5 Robotic Surgical System
da Vinci Xi Robotic Surgical System

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Textbook Recovery
大体时间：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

次要结果测量

结果测量
大体时间
Total Opioid Consumption
大体时间：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
大体时间：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)
大体时间：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
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Instrument Tip Forces
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ohio State University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年9月5日

初级完成 (估计的)

2027年6月30日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2026年3月2日

首先提交符合 QC 标准的

2026年6月16日

首次发布 (实际的)

2026年6月22日

研究记录更新

最后更新发布 (实际的)

2026年6月22日

上次提交的符合 QC 标准的更新

2026年6月16日

最后验证

2026年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • STUDY20250072

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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