Feasibility of Enhanced Recovery After Surgery Without Prophylactic Abdominal Drainage Tubes After Laparoscopic Distal Gastrectomy For Gastric Cancer: A Prospective, Multicenter, Non-inferiority, Randomized, Open-label, Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 454
- 试验地点
- 6
- 主要终点
- Cumulative incidence of reoperation and/or percutaneous drainage placement by the 30th postoperative day.
研究概览
简要总结
This study aims to compare the effects of using prophylactic abdominal drainage tubes during Enhanced Recovery After Surgery (ERAS) in patients undergoing Laparoscopic Distal Gastrectomy (LDG) for gastric cancer through a multicenter non-inferiority randomized trial. The study is divided into two groups: 1. ERAS-tubeless group: The ERAS protocol without nasogastric decompression, nasojejunal feeding or prophylactic abdominal drainage tubes. 2. ERAS-tube group: the ERAS protocol with prophylactic abdominal drainage tubes, along with no nasogastric decompression or nasojejunal feeding tubes. Patients will be randomly assigned to the two groups in a 1:1 ratio, with the primary analysis based on the modified intention-to-treat population (mITT) and secondary analysis on the per-protocol (PP) population. Perioperative management will adhere to ERAS guidelines, and postoperative quality of life will be assessed using the EORTC QLQ-C30 questionnaire and QoR-15 scores. Preliminary training on the standard ERAS protocol is administered to all members in the team before the initiation of the study, ensuring in-group members to fully master the requirements and other related contents in the study. Data collectors, analysts, and outcome evaluators will remain blinded to group allocation. The findings of this study are expected to provide high-quality evidence on the feasibility of omitting prophylactic abdominal drainage in the context of ERAS, thereby contributing to the optimization of postoperative management strategies for gastric cancer surgery.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients' age from 18 to 80 years old;
- •Histopathologically confirmed gastric adenocarcinoma;
- •Clinical tumor stage of cT1-4N0-3M0;
- •Laparoscopic distal gastrectomy approach;
- •ECOG score of 0-1;
- •Written informed consent
排除标准
- •Patients with severe concurrent illness or comorbid diseases;
- •Patients with severe pyloric obstruction, recurrent or remnant gastric cancer;
- •Patients with perforation, or undergoing emergency surgery;
- •4. Patients with a history of radiotherapy;
- •Patients undergoing complex abdominal surgeries other than laparoscopic cholecystectomy or appendectomy;
- •Patients with peritoneal, hepatic or ovarian metastasis, or simultaneous tumors in other parts of the body preoperatively and intraoperatively;
- •Patients with diabetes and poor recent glycemic control;
- •Patients with autoimmune diseases who have received corticosteroid treatment;
- •Patients with a BMI ≥30 kg/m2 or <18 kg/m2;
- •Patients with gastrointestinal hemorrhage and hemoglobin levels below 90 g/L;
- •Patients with hypoproteinemia and albumin levels below 30 g/L;
- •Patients with portal hypertension;
- •Patients with severe edema or dense fibrosis intraoperatively after neoadjuvant therapy;
- •Patients with intraoperative findings of duodenal invasion;
- •Patients with combined organ resection;
- •Reconstruction different from BillrothⅡand Braun anastomosis;
- •Patients with preoperative pathological examination inconsistent with postoperative result;
- •Declined to participate;
- •Patients with poor compliance and withdrew from the study halfway
研究组 & 干预措施
ERAS-tubeless group
Nasogastric decompression tube is not placed preoperatively; If necessary, nasogastric decompression tube is placed after anesthesia induction during surgery and removed when the reconstruction is performed; No abdominal drainage and nasojejunal feeding tubes were placed intraoperatively; None of these 3 tubes were present postoperatively.
干预措施: ERAS-tubeless group (Procedure)
ERAS-tube group
Nasogastric decompression tube is not placed preoperatively; If necessary, nasogastric decompression tube is placed after anesthesia induction during surgery and removed when the reconstruction is performed; Nasojejunal feeding tube is not placed intraoperatively; 1 prophylactic abdominal drainage tube is placed at the duodenal stump for LDG and retained postoperatively.
干预措施: ERAS-tube group (Procedure)
结局指标
主要结局
Cumulative incidence of reoperation and/or percutaneous drainage placement by the 30th postoperative day.
时间窗: The 30th day after surgery
It refers to the total proportion of patients who, by the 30th day after their surgery, undergo either a reoperation or the placement of a percutaneous drainage device. The cumulative incidence considers all patients who experience one or both of these outcomes by the 30th day after surgery, providing insight into the postoperative recovery process.
次要结局
- Postoperative hospital stay(It is expected to take 6 to 10 days)
- Overall 30 days morbidity or in hospital if longer than 30 days.(The 30th day after surgery)
- 30 days readmission rate and overall 90 days mortality.(Postoperative Day 30 and Day 90)
- EORTC QLQ-C30(Baseline, Postoperative Day 7 and Day 30)
- Quality of postoperative recovery.(Baseline, Postoperative Day 1, Day 2, Day 3, Day 4, Day 5, and the Day of Discharge)
- Time to first ambulation, time to first flatus, and time to first liquid diet.(It is expected to take 1 to 5 days.)
- NRS score.(The period is from the day of surgery to the day of discharge, which is expected to be approximately 7 days.)
- PNI value.(The period is from the day of surgery to the day of discharge, which is expected to be approximately 7 days.)
- Medical cost.(The period is from the date of hospital admission to discharge, which is expected to take approximately 8 days.)
研究者
Zuoyi Jiao
Medical Professor
Lanzhou University Second Hospital