Back to resultsRobotic Versus Video-assisted Lobectomy/Segmentectomy for Lung Surgery
Primary Purpose
Lung Diseases, Surgery
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
robotic surgery
uniport surgery
multiple- port surgery
Sponsored by
About this trial
This is an interventional treatment trial for Lung Diseases focused on measuring robotic surgery, VATS, uniport, multiport
Eligibility Criteria
Inclusion Criteria:
- good cardio- pulmonary function to tolerate surgery;
- minimaly invasive surgery for lobectomy or segmentectomy or sleeve lobectomy;
Exclusion Criteria:
- cardio- pulmonary function is not good enough to tolerate surgery;
- huge tumor or extensive adhesion in thoracic cavity.
Sites / Locations
- The Second Hospital of Shandong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
robotic surgery group
uniport surgery group
multiple- port surgery group
Arm Description
minimally invasive lung surgery using the Davinci robotic system to assist.
VATS minimally invasive lung surgery under the uniportal status.
VATS minimally invasive lung surgery under the multiple- port status.
Outcomes
Primary Outcome Measures
mortality
incidence rate
conversion rate to open surgery
incidence rate
postoperative complications
incidence rate
operation time
minutes
duration of hospitalization
days
days to tube removal
days
retrieved lymph node
amount
retrieved lymph node station
amount
short- term PFS
proportion
short- term overall survival
proportion
Secondary Outcome Measures
Full Information
NCT ID
NCT05270616
First Posted
February 27, 2022
Last Updated
February 27, 2022
Sponsor
The Second Hospital of Shandong University
1. Study Identification
Unique Protocol Identification Number
NCT05270616
Brief Title
Robotic Versus Video-assisted Lobectomy/Segmentectomy for Lung Surgery
Official Title
Robotic Versus Video-assisted Lobectomy/Segmentectomy for Lung Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Hospital of Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Surgery
Keywords
robotic surgery, VATS, uniport, multiport
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
robotic surgery group
Arm Type
Experimental
Arm Description
minimally invasive lung surgery using the Davinci robotic system to assist.
Arm Title
uniport surgery group
Arm Type
Active Comparator
Arm Description
VATS minimally invasive lung surgery under the uniportal status.
Arm Title
multiple- port surgery group
Arm Type
Active Comparator
Arm Description
VATS minimally invasive lung surgery under the multiple- port status.
Intervention Type
Procedure
Intervention Name(s)
robotic surgery
Intervention Description
minimally invasive surgery using the Davinci robotic system
Intervention Type
Procedure
Intervention Name(s)
uniport surgery
Intervention Description
VATS minimally invasive surgery under the uniportal status
Intervention Type
Procedure
Intervention Name(s)
multiple- port surgery
Intervention Description
VATS minimally invasive surgery under the multiple- port status
Primary Outcome Measure Information:
Title
mortality
Description
incidence rate
Time Frame
30 days after surgery
Title
conversion rate to open surgery
Description
incidence rate
Time Frame
during surgery
Title
postoperative complications
Description
incidence rate
Time Frame
within 7 days after surgery
Title
operation time
Description
minutes
Time Frame
within 180 minutes
Title
duration of hospitalization
Description
days
Time Frame
within 7 days after surgery
Title
days to tube removal
Description
days
Time Frame
within 7 days after surgery
Title
retrieved lymph node
Description
amount
Time Frame
within 1 days after surgery
Title
retrieved lymph node station
Description
amount
Time Frame
within 1 days after surgery
Title
short- term PFS
Description
proportion
Time Frame
3 years
Title
short- term overall survival
Description
proportion
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
good cardio- pulmonary function to tolerate surgery;
minimaly invasive surgery for lobectomy or segmentectomy or sleeve lobectomy;
Exclusion Criteria:
cardio- pulmonary function is not good enough to tolerate surgery;
huge tumor or extensive adhesion in thoracic cavity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaogang Zhao
Phone
+8617660080007
Email
zhaoxiaogang@sdu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yunpeng Zhao
Phone
18766188692
Email
zyp_baggio@163.com
Facility Information:
Facility Name
The Second Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250033
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunpeng Zhao, doctor
Phone
+8618766188692
12. IPD Sharing Statement
Learn more about this trial
Robotic Versus Video-assisted Lobectomy/Segmentectomy for Lung Surgery
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