RCT of Uniport VATS for Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Trial of the Comparison of Uniport VATS and Non- Uniport VATS for Lung Cancer

Conditions
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Single-port Video-assisted Thoracoscopic Surgery

Intervention / Treatment
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* Procedure: uniport video-assisted thoracoscopic surgery
* Procedure: two ports video-assisted thoracoscopic surgery
* Procedure: three ports video-assisted thoracoscopic surgery


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single port group<br>Uniport video-assisted thoracoscopic surgery for NSCLC | Procedure: uniport video-assisted thoracoscopic surgery<br>* video-assisted thoracoscopic surgery for NSCLC using single port or two ports or three ports<br>|
| Active Comparator: two ports group<br>video-assisted thoracoscopic surgery for NSCLC using two ports | Procedure: two ports video-assisted thoracoscopic surgery<br>* video-assisted thoracoscopic surgery for NSCLC using two ports<br>|
| Active Comparator: three ports group<br>video-assisted thoracoscopic surgery for NSCLC using three ports | Procedure: three ports video-assisted thoracoscopic surgery<br>* video-assisted thoracoscopic surgery for NSCLC using three ports<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | overall survival in rate | up to 5 years | 
| progression- free survival | progression- free survival in rate | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Small Cell Lung Cancer, Perioperative Efficacy, multi-port