RCT of Uniport VATS for Lung Cancer

The Second Hospital of Shandong University

Status: Enrolling

Conditions: Single-port Video-assisted Thoracoscopic Surgery

Treatments: Procedure: uniport video-assisted thoracoscopic surgery; Procedure: two ports video-assisted thoracoscopic surgery; Procedure: three ports video-assisted thoracoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04212481

Uniport VATS ZYP1

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

300 participants in 3 patient groups

single port group

Experimental group

Description:

Uniport video-assisted thoracoscopic surgery for NSCLC

Treatment:

Procedure: uniport video-assisted thoracoscopic surgery

two ports group

Active Comparator group

Description:

video-assisted thoracoscopic surgery for NSCLC using two ports

Treatment:

Procedure: two ports video-assisted thoracoscopic surgery

three ports group

Active Comparator group

Description:

video-assisted thoracoscopic surgery for NSCLC using three ports

Treatment:

Procedure: three ports video-assisted thoracoscopic surgery