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RCT of Uniport VATS for Lung Cancer

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04212481
Enrollment
300
Registered
2019-12-27
Start date
2019-12-25
Completion date
2025-12-30
Last updated
2022-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Single-port Video-assisted Thoracoscopic Surgery

Keywords

Non Small Cell Lung Cancer, Perioperative Efficacy, multi-port

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.

Interventions

PROCEDUREuniport video-assisted thoracoscopic surgery

video-assisted thoracoscopic surgery for NSCLC using single port or two ports or three ports

PROCEDUREtwo ports video-assisted thoracoscopic surgery

video-assisted thoracoscopic surgery for NSCLC using two ports

PROCEDUREthree ports video-assisted thoracoscopic surgery

video-assisted thoracoscopic surgery for NSCLC using three ports

Sponsors

The Second Hospital of Shandong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
complicationsup to 3 monthscomplications in rate
length of hospital staywithin 5-7 dayslength of hospital stay in days
visual analogue score of postoperative painwithin 5-7 daysscore
operative time1 dayoperative time in minutes
perioperative blood loss1 dayperioperative blood loss in milliliter
conversion rate1 dayconversion rate in proportion
duration of postoperative drainagewithin 5-7 daysduration of postoperative drainage in days

Secondary

MeasureTime frameDescription
progression- free survivalup to 5 yearsprogression- free survival in rate
overall survivalup to 5 yearsoverall survival in rate

Countries

China

Contacts

Primary ContactYunpeng Zhao, Doctor
zyp_baggio@163.com+8618766188692

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026