Minimally Invasive or Open Surgery for Lung Cancer: Pain, Quality of Life and Economics.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 294
- 试验地点
- 2
- 主要终点
- Postoperative pain
研究概览
简要总结
Is thoracoscopic surgery better than traditional open surgery for lung cancer?
Video assisted thoracoscopic surgery for lung cancer (VATS) is presumed to be less traumatic than traditional open surgery for lung cancer but this has never been documented in a randomized trial. Some surgeons hesitate to use VATS because it is technically more demanding, others question if the two methods are oncologically equal. Regardless, VATS has been implemented as a routine method for lung cancer surgery several places around the world including Odense University Hospital. The investigators have launched the first randomized controlled trial in the world comparing the two surgical methods to investigate any differences in length of hospitalization, postoperative pain, life quality within the first year, and health economics.
The investigators include patients with stage I and II lung cancer, and randomize between VATS and open surgery in a design where both the patient and doctors doing general rounds in the ward are blinded until discharge because the dressing on the surgical wound is identical, regardless of the surgical method. The surgeon cannot influence clinical decisions including time to discharge, which is decided by other specialist surgeons. Pain evaluation is performed 6 times daily using the VAS-score, life quality is evaluated continuously during the first 12 months using EQ5D and EORTC QLQC-30 questionnaires, and the consumption of analgetics in both groups are monitored via the national prescription database.
Parallel to this trial a similar clinical study, which is also the first of its kind in the world, has been launched for patients with lung cancers not eligible for VATS. They are randomized between the two traditional open surgical methods (anterolateral and posterolateral thoracotomy) - this is also blinded to both patient and doctors doing rounds until discharge from hospital, and endpoint are similar in the two studies.
206 patients have been randomized in the first substudy (VATS vs. open) and 88 in the second substudy (posterolateral vs. anterolateral).
详细描述
Is minimally invasive surgery for non small cell lung cancer better than traditional open surgery?
Surgical resection remains the best treatment for non small cell lung carcinoma (NSCLC),but unfortunately many patients suffer major postoperative morbidity - pain being the most frequent. It is assumed that newer minimally invasive surgical techniques (Video Assisted Thoracoscopic Surgery - VATS) reduces postoperative morbidity but there is no level 1 evidence available in the literature. This prompted us to perform the present ongoing study, which is the first of its kind in the world.
The investigators compare VATS with traditional open surgery for early stage lung cancer in a clinical randomized double blinded trial. Our aims are to evaluate differences in postoperative pain, life quality, and health economical aspects. The results of this trial could influence future surgical decisionmaking internationally on the surgical treatment for lung cancer.
Likewise, in patients with larger tumours of the lung, which are not suitable for minimally invasive surgery, different techniques are available. The most widely used techniques are the posterolateral thoracotomy and the anterolateral thoracotomy. So far no randomized controlled trail has shown which of these techniques to be superior. This has led us to also randomize between anterolateral and the posterolateral thoracotomy (muscle sparing). The same endpoints are used.
Pain following lung surgery has been a much discussed topic for a long time in the field of thoracic surgery. Depending on the reference, up to 50% of patients develop chronic pain after open lung surgery. Therefore, different surgical approaches have been developed including anterior, lateral or posterior thoracotomy with or without sparing the chest wall muscles. The intercostal nerve is also of concern because of trauma from the rib retractor which is believed to be a cause of both acute and chronic pain. Other concerns are the amount of divided tissue, extend of rib displacement by the rib retractor, type of analgesics, administration form of analgesics, and administration time of the analgesics and it is generally accepted that pain in lung cancer patients is multifactorial.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for surgery for lunge cancer.
- •Elective surgery (surgery planed > 2 days)
- •Accepts randomization
- •Age 18 or above.
排除标准
- •Previous thoracic surgery
- •Planned segment resection or pneumonectomy.
- •Any type of chronic pain, requiring daily use of analgetics
- •Breast feeding
- •T3, T4 tumors or cerebral tumors.
- •contraindications to NSAID
- •Chemo- and/or radiotherapy in connection to present admission.
- •Major surgery planned in connection to this admission.
结局指标
主要结局
Postoperative pain
时间窗: 12 months
Aim is to asses the development of acute and chronic pain after lobectomy.
次要结局
- Quality of life(12 months)
- Economy(12 months)
研究者
Peter B Licht
Professor, MD, pHd.
Odense University Hospital