Comparison of Safety and Perioperative Outcomes of Subxiphoid Approach Versus Lateral Intercostal Approach Thoracoscopic Thymectomy for Masaoka-Koga I-II Thymoma: A Prospective, Open, Multi-center, Phase II Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Dosage of analgesic medication after surgery
研究概览
简要总结
The purpose of this study was to evaluate the safety and perioperative outcomes of the subxiphoid approach versus the lateral intercostal approach thoracoscopic thymectomy for Masaoka-Koga I-II thymoma.
详细描述
It is a multi-center, open, prospective randomized phase II&III clinical trial sponsored by Shanghai Zhongshan Hospital with other four hospitals in China participating in. 100 patients with thymoma (Masaoka-Koga I-II ) diagnosed by enhanced computed tomography were recruited and randomly assigned into the subxiphoid approach thoracoscopic thymectomy (SATT group) and the lateral intercostal approach thoracoscopic thymectomy (LATT group) according to the proportion of 1:1. The safety and perioperative outcomes are compared between the two surgical regimens.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thymoma was diagnosed by chest enhanced CT (clinical stage: Masaoka Koga I-II);
- •The patients whose tumor diameter was <6 cm;
- •The patients with age ≥ 18 and ≤ 75 years old, the estimated survival time should be over 12 months;
- •ASA grade：1-2;
- •The patients should have no functional disorders in main organs.;
- •The patients should be able to understand our research and sign the informed consent.
排除标准
- •Imaging examination showed that the tumor had invasion of surrounding organs, pleural or pericardial dissemination, lymphatic or hematogenous metastasis;
- •Patients with myasthenia gravis;
- •Patients had undergone a sternotomy;
- •The patients have proved history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control;
- •The patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy;
- •Female who is positive for serum pregnancy test or during lactation period;
- •The patients have history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation;
- •The patients have history of peripheral nerve system disorders, obvious mental disorders or central nerve system disorders;
- •The patients attend other clinical trials.
结局指标
主要结局
Dosage of analgesic medication after surgery
时间窗: Up to the date of hospital discharge since the data of completion of surgery, up to 7 days
The dosage of postoperative analgesic medication was the sum of the dosage of analgesics used for managing the pain of the patient after surgery. The analgesic medication includes analgesics in patient-controlled epidural analgesia (PCIA), injections, and oral medication.
Visual Analog Scales scores for postoperative pain
时间窗: Up to the date of hospital discharge since the data of completion of surgery, up to 7 days
The postoperative pain was evaluated for every enrolled patient by using the Visual Analog Scales (VAS). VAS: it typically asks a patient to place a mark on a line indicating the level of pain from 0 to 10. Zero indicates the absence of pain, while 10 represents the most intense pain possible.
Postoperative hospital stay
时间窗: Up to the date of meeting the criteria of hospital discharge since the data of surgery, up to 1 month
Postoperative hospital stay is the duration for every enrolled patient until the date of meeting the criteria of hospital discharge since the date of surgery. The criteria of hospital discharge were defined as with the volume of postoperative drainage \< 200 ml/day, a normal chest X-ray, and good physical condition.
次要结局
- Operative time(The duration until the finish of surgery since the start of the surgery, up to 5 hours)
- Perioperative blood loss(The duration until the finish of surgery since the start of the surgery, up to 5 hours)
- Rate of conversion to open thoracotomy(Up to the end of follow-up since the date of randomization, up to 6 months.)
- Volume of postoperative drainage(Up to the date of removal of drainage equipment since the data of completion of surgery, up to 7 days)
- Postoperative treatment-related complications(Up to the date of hospital discharge since the data of completion of surgery, up to 7 days.)
- Chronic postsurgical pain(Up to the end of follow-up since the date of hospital discharge, up to 6 months.)
- EORTC QLQ-C30 score for overall quality of life(Up to the end of follow-up since the date of randomization, up to 6 months.)