Robotic Versus Video-assisted Lobectomy/Segmentectomy for Lung Surgery

February 27, 2022 updated by: The Second Hospital of Shandong University

To compare the safety/efficacy of the robotic-assisted lobectomy/segmentectomy (RAL/S) with the video-assisted lobectomy/segmentectomy (VAL/S) for lung resection.

Video-assisted lobectomy/segmentectomy (VAL/S) for lung resection is divided into uniport group and multiple- port group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250033
        • Recruiting
        • The Second Hospital of Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. good cardio- pulmonary function to tolerate surgery;
  2. minimaly invasive surgery for lobectomy or segmentectomy or sleeve lobectomy;

Exclusion Criteria:

  1. cardio- pulmonary function is not good enough to tolerate surgery;
  2. huge tumor or extensive adhesion in thoracic cavity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: robotic surgery group
minimally invasive lung surgery using the Davinci robotic system to assist.
Procedure: robotic surgery
minimally invasive surgery using the Davinci robotic system
Active Comparator: uniport surgery group
VATS minimally invasive lung surgery under the uniportal status.
Procedure: uniport surgery
VATS minimally invasive surgery under the uniportal status
Active Comparator: multiple- port surgery group
VATS minimally invasive lung surgery under the multiple- port status.
Procedure: multiple- port surgery
VATS minimally invasive surgery under the multiple- port status

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 30 days after surgery
incidence rate
30 days after surgery
conversion rate to open surgery
Time Frame: during surgery
incidence rate
during surgery
postoperative complications
Time Frame: within 7 days after surgery
incidence rate
within 7 days after surgery
operation time
Time Frame: within 180 minutes
minutes
within 180 minutes
duration of hospitalization
Time Frame: within 7 days after surgery
days
within 7 days after surgery
days to tube removal
Time Frame: within 7 days after surgery
days
within 7 days after surgery
retrieved lymph node
Time Frame: within 1 days after surgery
amount
within 1 days after surgery
retrieved lymph node station
Time Frame: within 1 days after surgery
amount
within 1 days after surgery
short- term PFS
Time Frame: 3 years
proportion
3 years
short- term overall survival
Time Frame: 3 years
proportion
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2028

Study Registration Dates

First Submitted

February 27, 2022

First Submitted That Met QC Criteria

February 27, 2022

First Posted (Actual)

March 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

February 27, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Robotic lung ZYP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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