RCT of Uniport VATS for Lung Cancer

Not Applicable

Recruiting

• Conditions: Single-port Video-assisted Thoracoscopic Surgery
• Interventions: Procedure: uniport video-assisted thoracoscopic surgery; Procedure: two ports video-assisted thoracoscopic surgery; Procedure: three ports video-assisted thoracoscopic surgery

• Registration Number: NCT04212481
• Lead Sponsor: The Second Hospital of Shandong University

Brief Summary

Video-assisted thoracoscopic surgery (VATS) has been widely used for non-small cell lung cancer (NSCLC) for nearly two decades. Usually, it was applied through three ports with at least one drainage after surgery, which often lead to acute chest pain. Therefore, fewer, smaller ports, and wider intercostal space for surgery has been required.

Uniport VATS became a feasible option with the development of surgical techniques and instruments, with potentially less postoperative pain and shorter hospital stays. However, there may be some complications, or with a longer time of operation, even more difficult in lymph nodes resection during learning curve.

In our study, a Randomized Controlled Trial was designed to study the operation time, perioperative blood loss, conversion rate, duration of postoperative drainage, length of hospital stay, visual analogue score of postoperative pain, complications, and survival.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-21
• Study Start: 2019-12-25
• Study First Submitted QC: 2019-12-25
• Study First Posted: 2019-12-27
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-16
• Primary Completion: 2022-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

patients with cT1-3N0-1M0 NSCLC; good cardiopulmonary function; prepared to undergo radical resection;

Exclusion Criteria

patients with N3 or M1 NSCLC; poor cardiopulmonary function; not be prepared to undergo radical resection;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single port group	uniport video-assisted thoracoscopic surgery	Uniport video-assisted thoracoscopic surgery for NSCLC
two ports group	two ports video-assisted thoracoscopic surgery	video-assisted thoracoscopic surgery for NSCLC using two ports
three ports group	three ports video-assisted thoracoscopic surgery	video-assisted thoracoscopic surgery for NSCLC using three ports

Primary Outcome Measures

Name	Time	Method
perioperative blood loss	1 day	perioperative blood loss in milliliter
conversion rate	1 day	conversion rate in proportion
length of hospital stay	within 5-7 days	length of hospital stay in days
visual analogue score of postoperative pain	within 5-7 days	score
operative time	1 day	operative time in minutes
duration of postoperative drainage	within 5-7 days	duration of postoperative drainage in days
complications	up to 3 months	complications in rate

Secondary Outcome Measures

Name	Time	Method
progression- free survival	up to 5 years	progression- free survival in rate
overall survival	up to 5 years	overall survival in rate

Trial Locations

Locations (1)

The Second Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China