Overcoming Instrumentation Challenges in Real-World Uniportal Video-Assisted Thoracoscopic Surgery: A Prospective, Randomized, Controlled Trial Evaluating the SurgeoFlex Grasp Versus the Traditional Endograsper for Systemic Lymph Node Dissection in Patients With Early-Stage Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Duration of Systemic Lymph Node Dissection (SLND)
研究概览
简要总结
This study is testing whether a new, flexible surgical tool-the SurgeoFlex Grasp-makes keyhole chest operations for early-stage lung cancer easier, faster, and safer than the standard rigid tool used today.
What is the problem? In keyhole (uniportal) chest surgery, formally known as single-port video-assisted thoracoscopic surgery (VATS), surgeons reach the lung through one small incision between the ribs. Because the operating space is tight, the usual stiff instruments can bump into each other and into surrounding tissues. This difficulty can prolong lymph-node removal and increase the risk of complications.
What is being tested?
The trial compares two handheld tools:
SurgeoFlex Grasp (intervention): a slim, bendable grasper that can be steered around corners.
Traditional EndoGrasper (control): a straight, rigid grasper currently used as the standard.
Who is taking part? Approximately 100 adults with early-stage non-small-cell lung cancer (NSCLC) (tumours 3 cm or smaller) who are scheduled for keyhole surgery at The First Affiliated Hospital of Guangzhou Medical University.
What will happen?
Participants are allocated by randomisation into one of two groups:
SurgeoFlex group-surgeons use the new flexible tool. Control group-surgeons use the standard rigid tool. All other aspects of the operation, anaesthesia, and post-operative care remain identical for both groups.
What is measured? Lymphadenectomy time (duration required to remove the specified lymph nodes). Number of lymph nodes successfully removed. Frequency of surgical-instrument collisions or interference (instrument-clash events).
Surgeon workload during the operation (assessed with the National Aeronautics and Space Administration Task Load Index [NASA-TLX]).
Skin-incision length, pain scores (Visual Analogue Scale [VAS]), recovery time, infection rates, and overall cost.
Quality-of-life scores one month after surgery (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30] and its lung-cancer module [EORTC QLQ-LC13]).
What is expected? The investigators expect the SurgeoFlex Grasp to shorten operative time, reduce instrument interference, lower surgeon stress, and accelerate recovery without increasing cost.
How will this help patients? If the new tool performs as anticipated, future patients undergoing keyhole lung-cancer surgery may experience shorter operations, smaller scars, less pain, and lower infection risk while still obtaining complete cancer-related lymph-node removal.
Where is the study taking place? The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Contact for more information:
Clinical Research Management Committee 151 Yanjiang Road, Yuexiu District, Guangzhou 510120, China Email: crmc@gzhmu.edu.cn
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria
- •Inclusion Criteria
- •Age 18-70 years, any sex
- •BMI 18.5-30 kg/m²
- •Newly diagnosed non-small-cell lung cancer with pre-operative clinical stage cT1-2N0-1M0
- •Scheduled to undergo single-port video-assisted thoracoscopic lobectomy with systematic lymph-node dissection
- •Major organ function sufficient for surgery
- •Written informed consent provided
排除标准
- •Small-cell lung cancer or mixed-type lung cancer
- •Tumor invasion of main bronchus, chest wall, diaphragm, or major mediastinal vessels
- •Previous ipsilateral thoracic surgery or prior neoadjuvant chemotherapy, radiotherapy, targeted therapy, or immunotherapy
- •Severe cardiopulmonary dysfunction (FEV₁ <50 % predicted or LVEF <40 %)
- •Pregnant or breastfeeding women
- •Participation in another interventional clinical trial
结局指标
主要结局
Duration of Systemic Lymph Node Dissection (SLND)
时间窗: Intraoperative; measured from the start of the first lymph node packet dissection to the completion of the final packet removal, up to a maximum of 60 minutes.
次要结局
- Number of Lymph Nodes Retrieved(Intraoperatively, assessed immediately after the completion of systemic lymph node dissection.)
- Instrument Collision Counts(Intraoperatively, continuously recorded during systemic lymph node dissection and averaged per case.)
- Surgeon Cognitive Load (NASA-TLX score)(Intra-operatively, within 10 minutes after skin closure.)
- Skin Incision Length(At the end of the operation, before skin closure.)
- Post-operative Pain Score (0-10 numeric rating scale)(Daily during the first 3 post-operative days.)
- Incidence of Post-operative Infections(Within 30 days after surgery.)
- Operating Room Occupancy Time(Time Frame: Intra-operatively, from skin incision to wound closure, up to 6 hours.)
- Health-related Quality of Life (SF-36 score)(Assessed 1 month after surgery.)
- Incidence of Device Malfunction(From device insertion to device removal, assessed continuously during each operation.)
研究者
Jianxing He
Professor and Chair
The First Affiliated Hospital of Guangzhou Medical University