Robotic Versus Video-assisted Lobectomy/Segmentectomy for Lung Surgery

Surgery Clinical Trial

Official title:

Robotic Versus Video-assisted Lobectomy/Segmentectomy for Lung Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05270616
• Other study ID #: Robotic lung ZYP
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 1, 2028

Study information

• Verified date: February 2022
• Source: The Second Hospital of Shandong University
• Contact: Xiaogang Zhao
• Phone: +8617660080007
• Email: zhaoxiaogang[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: June 1, 2028
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Surgery

Intervention

Procedure:
• robotic surgery
minimally invasive surgery using the Davinci robotic system
• uniport surgery
VATS minimally invasive surgery under the uniportal status
• multiple- port surgery
VATS minimally invasive surgery under the multiple- port status

Locations

Country	Name	City	State
China	The Second Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

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