Robotic Versus Video-assisted Lobectomy/Segmentectomy for Lung Surgery

Sponsor
The Second Hospital of Shandong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05270616
Collaborator
(none)
800
1
3
96
8.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: robotic surgery
  • Procedure: uniport surgery
  • Procedure: multiple- port surgery
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Robotic Versus Video-assisted Lobectomy/Segmentectomy for Lung Surgery
Actual Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2028

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. mortality [30 days after surgery]

    incidence rate

  2. conversion rate to open surgery [during surgery]

    incidence rate

  3. postoperative complications [within 7 days after surgery]

    incidence rate

  4. operation time [within 180 minutes]

    minutes

  5. duration of hospitalization [within 7 days after surgery]

    days

  6. days to tube removal [within 7 days after surgery]

    days

  7. retrieved lymph node [within 1 days after surgery]

    amount

  8. retrieved lymph node station [within 1 days after surgery]

    amount

  9. short- term PFS [3 years]

    proportion

  10. short- term overall survival [3 years]

    proportion

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Second Hospital of Shandong University Jinan Shandong China 250033

Sponsors and Collaborators

  • The Second Hospital of Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Second Hospital of Shandong University
ClinicalTrials.gov Identifier:
NCT05270616
Other Study ID Numbers:
  • Robotic lung ZYP
First Posted:
Mar 8, 2022
Last Update Posted:
Mar 8, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Second Hospital of Shandong University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2022