POsitioning for Esophageal Cancer Resection - a Randomized Controlled TRIal (POETRI)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- operating time
研究概览
简要总结
Open thoracoabdominal esophagectomy (TAE) is the standard curative treatment modality for resectable esophageal cancer. TAE can be achieved by positioning the patient in the supine position for the abdominal part and in a left-lateral decubitus (LLD) position for the thoracic part, or by performing both parts in a left-screwed supine position (LSS). Aim of the present study is to compare peri- and postoperative outcome variables after TAE for esophageal cancer in the two positions.
POETRI is designed as a single-center, randomized controlled trial with two parallel arms including patients with resectable esophageal cancer and type I cancers of the esophagogastric junction (AEG I). Exclusion criteria are inability to tolerate surgery or both types of positioning, inability to perform an intrathoracic anastomosis, non-malignant pathologies. The primary endpoint is operating time. Secondary endpoints are morbidity, lymph node yield, pulmonary function, pain control and wound healing assessed during a follow-up of 3 months.
POETRI is a single-center, randomized controlled trial to evaluate different positioning and thoracic access during radical open thoracoabdominal esophagectomy for patients with resectable esophageal cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed, non-metastatic esophagus cancer (squamous or adenocarcinoma) or AEG I tumors requiring curative thoracoabdominal esophagectomy with intrathoracic anastomosis of a gastric tube immediately after diagnosis or after neoadjuvant treatment
- •Patients are considered fit for surgery by a local interdisciplinary team of surgeons, medical oncologists and anesthesiologists (ECOG performance status of 0,1, or 2).
- •Age ≥ 18 years
- •Written informed consent
排除标准
- •Preoperative established indication for colon interposition or cervical anastomosis
- •Preoperative diagnosed tracheo-esophageal fistula
- •History of right thoracotomy or prior lung surgery
- •Physical inability of the described intraoperative patient positioning
- •Non-malignant esophageal pathology or other malignancies except squamous or adenocarcinoma
- •Planned laparoscopic or thoracoscopic surgical approach
- •Patients not eligible for TAE (ASA ≥ 4)
研究组 & 干预措施
Repositioning Group
The patient is placed on a vacuum mattress in supine position for the abdominal part using a midline laparotomy. After completion of the abdominal part, the abdomen is closed and dressed in standard fashion and the patient is repositioned under full anesthesia is a left-lateral decubitus (LLD) position. After the thorax is sterile prepped and draped, a right dorso-lateral thoracotomy in the 4th to 6th intercostal space under preservation of body of the serratus muscle is performed.
干预措施: Repositioning (Procedure)
Single positioning
The patient is placed on a vacuum mattress and in a left-screwed supine position for the entire operative procedure. The pelvis and the lower extremities are placed at 0° rotation, whereas the torso is rotated leftwards to an angle of 45° (Fig. 1). The patient is prepped and draped from the shoulders to the inguinal region. A midline laparotomy is done for the abdominal part and the abdomen closed afterwards. For the thoracic part, the operating table is tilted about 30° to the left, and a right anterolateral thoracotomy is performed in the 4th to 6th intercostal space.
干预措施: Single positioning (Procedure)
结局指标
主要结局
operating time
时间窗: The endpoint is assessed at the end of the operation (finishing of all wound dressings) on the day of operation.
Operating time is defined from the start of patient positioning until final closing and dressing of all wounds.
次要结局
未报告次要终点