Single-port Video-assisted Thoracoscopic Surgery Clinical Trial
Official title:
Randomized Controlled Trial of the Comparison of Uniport VATS and Non- Uniport VATS for Lung Cancer
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.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | December 30, 2025 |
| Est. primary completion date | December 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 25 Years to 80 Years |
| Eligibility | 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; |
| Country | Name | City | State |
|---|---|---|---|
| China | The Second Hospital of Shandong University | Jinan | Shandong |
| Lead Sponsor | Collaborator |
|---|---|
| The Second Hospital of Shandong University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | operative time | operative time in minutes | 1 day | |
| Primary | perioperative blood loss | perioperative blood loss in milliliter | 1 day | |
| Primary | conversion rate | conversion rate in proportion | 1 day | |
| Primary | duration of postoperative drainage | duration of postoperative drainage in days | within 5-7 days | |
| Primary | length of hospital stay | length of hospital stay in days | within 5-7 days | |
| Primary | visual analogue score of postoperative pain | score | within 5-7 days | |
| Primary | complications | complications in rate | up to 3 months | |
| Secondary | overall survival | overall survival in rate | up to 5 years | |
| Secondary | progression- free survival | progression- free survival in rate | up to 5 years |