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.
Patients' age from 18 to 80 years old;
Histopathologically confirmed gastric adenocarcinoma;
Clinical tumor stage of cT1-4N0-3M0;
Laparoscopic distal gastrectomy approach;
Patients with severe concurrent illness or comorbid diseases;
Patients with severe pyloric obstruction, recurrent or remnant gastric cancer; 3. Patients with perforation, or undergoing emergency surgery;
Parallel
ERAS-tubeless group
Procedure/SurgeryNasogastric 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.
ERAS-tube group
Procedure/SurgeryNasogastric 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.
Cumulative incidence of reoperation and/or percutaneous drainage placement by the 30th postoperative day.
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.
Postoperative hospital stay
Postoperative hospital stay is considered as a period from the time when a patient leaves the operating room to the point of time (8:00 am) on the day of discharge with no intervention treatment provided.
Overall 30 days morbidity or in hospital if longer than 30 days.
The intraoperative complications include surgery-related complications (intraoperative hemorrhage (≥400 mL) and injury of liver, spleen, pancreas, and other vital organs), pneumoperitoneum-related complications (hypercapnia, mediastinal emphysema, subcutaneous emphysema, and respiratory and circulatory instability caused by pneumoperitonum), and anesthesia-related complications (acute bronchospasm, aspiration, abnormal blood pressure and temperature, and allergic reaction). The postoperative complications are defined as any adverse events requiring surgical or medical interventions after surgery, including surgery-related complications (wound problems, anastomotic leakage, anastomotic hemorrhage, anastomotic stenosis, intra-abdominal hemorrhage, intra-abdominal abscess, ileus, gastroparesis, lymphatic leakage, unscheduled reoperation, and surgery-related readmission) and system-related complications (pulmonary infection, pulmonary embolism, cardio-cerebrovascular complications (includ
30 days readmission rate and overall 90 days mortality.
The 30 days readmission rate refers to the proportion of patients who are readmitted to a healthcare facility within 30 days after being discharged, attributable to postoperative complications. It is often used as a quality metric to assess healthcare effectiveness and the likelihood of complications or inadequate discharge planning. A higher readmission rate may indicate potential issues with the quality of care or patient management after discharge. The overall 90 days mortality refers to the proportion of patients who die within 90 days of either being admitted to or discharged from a healthcare facility, directly attributable to gastric cancer progression or surgery-related complications. This metric is used to evaluate the long-term survival rate of patients following their hospitalization and can serve as an indicator of the severity of the condition being treated, the effectiveness of treatment, and the overall healthcare system's ability to manage patients' long-term outcomes.
EORTC QLQ-C30
EORTC QLQ-C30 questionnaire scale is used to assess the quality of life in both two groups. The assessment will be performed preoperatively (baseline), and at 7th day and 1 month after surgery.
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Zuoyi Jiao
Lead sponsor
Lanzhou University Second Hospital
Sponsor institution
