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Feasibility of Enhanced Recovery After Surgery Without Prophylactic Abdominal Drainage Tubes After Laparoscopic Distal Gastrectomy For Gastric Cancer

RecruitingPhase 3Ages 18 Years - 80 YearsAllZuoyi Jiao
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In plain words

What the trial is, and whether it could suit you

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 lif

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients' age from 18 to 80 years old; 2. Histopathologically confirmed gastric adenocarcinoma; 3. Clinical tumor stage of cT1-4N0-3M0; 4. Laparoscopic distal gastrectomy approach; 5. ECOG score of 0-1; 6. Written informed consent Exclusion Criteria: 1. Patients with severe concurrent illness or comorbid diseases; 2. Patients with severe pyloric obstruction, recurrent or remnant gastric cancer; 3. Patients with perforation, or undergoing emergency surgery; 4\. Patients with a history of radiotherapy; 5. Patients undergoing complex abdominal surgeries other than laparoscopic cholecystectomy or appendectomy; 6. Patients with peritoneal, hepatic or ovarian metastasis, or simultaneous tumors in other parts of the body preoperatively and intraoperatively; 7. Patients with diabetes and poor recent glycemic control; 8. Patients with autoimmune diseases who have received corticosteroid treatment; 9. Patients with a BMI ≥30 kg/m2 or \<18 kg/m2; 10. Patients with gastrointestinal hemorrhage and hemoglobin levels below 90 g/L; 11. Patients with hypoproteinemia and albumin levels below 30 g/L; 12. Patients with portal hypertension; 13. Patients with severe edema or dense fibrosis intraoperatively after neoadjuvant therapy; 14. Patients with intraoperative findings of duodenal invasion; 15. Patients with combined organ resection; 16. Reconstruction different from BillrothⅡand Braun anastomosis; 17. Patients with preoperative pathological examination inconsistent with postoperative result; 18. Declined to participate; 19. Patients with poor compliance and withdrew from the study halfway
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What it tests

  • ERAS-tubeless group
  • ERAS-tube group
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Where

6 sites
International Hospital of Pecking University
Beijing, China
Fujian Medical University Union Hospital
Fuzhou, China
Lanzhou University Second Hospital
Lanzhou, China
Sun Yat-sen University Cancer Center Gansu Hospital
Lanzhou, China
Zhejiang Cancer Hospital
Zhejiang, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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