Robotic Versus Video-assisted Lobectomy/Segmentectomy for Lung Surgery
1 other identifier
interventional
800
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 27, 2022
CompletedFirst Posted
Study publicly available on registry
March 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
ExpectedMarch 8, 2022
February 1, 2022
3 years
February 27, 2022
February 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
mortality
incidence rate
30 days after surgery
conversion rate to open surgery
incidence rate
during surgery
postoperative complications
incidence rate
within 7 days after surgery
operation time
minutes
within 180 minutes
duration of hospitalization
days
within 7 days after surgery
days to tube removal
days
within 7 days after surgery
retrieved lymph node
amount
within 1 days after surgery
retrieved lymph node station
amount
within 1 days after surgery
short- term PFS
proportion
3 years
short- term overall survival
proportion
3 years
Study Arms (3)
robotic surgery group
EXPERIMENTALminimally invasive lung surgery using the Davinci robotic system to assist.
uniport surgery group
ACTIVE COMPARATORVATS minimally invasive lung surgery under the uniportal status.
multiple- port surgery group
ACTIVE COMPARATORVATS minimally invasive lung surgery under the multiple- port status.
Interventions
minimally invasive surgery using the Davinci robotic system
VATS minimally invasive surgery under the uniportal status
VATS minimally invasive surgery under the multiple- port status
Eligibility Criteria
You may qualify if:
- good cardio- pulmonary function to tolerate surgery;
- minimaly invasive surgery for lobectomy or segmentectomy or sleeve lobectomy;
You may not qualify if:
- cardio- pulmonary function is not good enough to tolerate surgery;
- huge tumor or extensive adhesion in thoracic cavity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Hospital of Shandong University
Jinan, Shandong, 250033, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2022
First Posted
March 8, 2022
Study Start
June 1, 2020
Primary Completion
June 1, 2023
Study Completion (Estimated)
June 1, 2028
Last Updated
March 8, 2022
Record last verified: 2022-02