A Randomised Multicentre Controlled Trial of Gastrectomy With or Without Prophylactic Abdominal Drainage. The Abdominal Drain in Gastrectomy Trial (ADiGe Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 404
- 试验地点
- 11
- 主要终点
- 30 day reoperation AND/OR additional drain placement
研究概览
简要总结
Prophylactic use of anastomotic drain in upper gastrointestinal surgery has been questioned in the last 15 years but only small studies have been conducted. In 2015 a Cochrane meta analysis on four Randomized Controlled Trials (RCT) concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless the Authors evidenced the moderate/low methodological quality of the included studies and highlighted how 3 out of four came from Eastern countries. Despite the above mentioned limits, Enhanced Recovery After Surgery (ERAS) society published the guidelines for gastrectomy that strongly recommend, with high evidence level, to avoid routine use of drain in gastric surgery. After 2015 some other retrospective studies have been published, all with inconsistent results. Our objective is to perform a multicentre prospective trial in a large western cohort of patients to establish wether avoid routine use of anastomotic drain does not led to an increasing of postoperative invasive procedure.
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
盲法说明
The leading surgeon and the patient will be blinded to the arm assigned until the end of the operation. No blinding is provided for the patient, care providers, or coordinating researcher after the operation. After the operation we thought that was unreliable to go ahead with participants blindness considering that one arm has an evident drain and the other arm has no drain. Considering that clinicians will need to check drain quality and remove the tube in treatment group we considered not possible to mask the care providers or investigators on this practice.
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
- •all consecutive patients that undergo total or subtotal gastrectomy with a curative intent, for histologically proven gastric cancer or esophago-gastric junction cancer Siewert type II or III, in surgical investigator centres from the beginning of the study until reaching the accrual number
- •esophageal involvement <= 2 cm
- •patients undergoing upfront surgery or treated with a neoadjuvant/perioperative chemotherapy
- •open, hybrid, laparoscopic or robotic approach
- •all types of anastomosis (circular stapled, linear stapled, hand sewn)
排除标准
- •refuse to sign informed consent
- •Heart failure New York Heart Association (NYHA) class IV
- •severe liver disease (Child >= 7)
- •pregnancy
- •metastatic disease
- •emergency surgery
- •palliative surgery
- •operation different from total or subtotal oncological gastrectomies (e.g. pylorus preserving, proximal gastrectomy)
- •lymphnodal dissection <D1
- •reconstruction different from Roux-en-Y or Billroth II
- •multiple organ resections (except for cholecystectomy)
- •gastric cancer with duodenal involvement
- •intraoperative Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
研究组 & 干预措施
No Drain
Participants enrolled in this arm do not have any abdominal drain placed at the end of the operation. Postoperative management (e.g. resume of oral intake, anastomosis integrity tests) is left to centre preference. Need for reoperation and/or percutaneous drain placement (primary outcome) are registered.
干预措施: Avoid drain placement (Device)
Drain
Participants enrolled in this arm have an abdominal drain positioned at the end of the operation (any type, inserted from right flank with the tip close to the esophago-jejunal or Gastro-jejunal anastomosis and the duodenal stump). Drain will stay in place until postoperative day (POD) 4th (drain output and quality will be registered). If normal drain debt and patient have no abdominal complications that need reoperation and/or percutaneous drain placement until POD 4, a methylene-blue test is be performed (200 ml water + 5 ml blue orally, check drain after 60 minutes: negative test if no blu was seen in the drain). If negative-blue test drain can be removed according to centre preference (no strict POD defined); if positive-blue test complication will be treated according to centre preference. Only in this arm drain related complications are registered. Need for reoperation and/or percutaneous drain placement (primary outcome) are registered.
干预措施: Drain placement (Device)
结局指标
主要结局
30 day reoperation AND/OR additional drain placement
时间窗: 30 days after the operation
Incidence of reoperation AND/OR percutaneous placement of an additional drain within postoperative day 30 (composite outcome)
次要结局
- Overall mortality(90 days after the operation)
- Length of hospital stay(From the day of operation until discharge (home or other facilities) or death for any cause whichever came first, assessed up to 100 months.)
- Drain related complications(From the day of operation until drain removal up to 90 days after the operation)
- Overall morbidity(30 days after the operation OR in hospital if hospitalization is longer than 30 days, up to 90 days of hospitalization)