Feasibility of Enhanced Recovery After Surgery Without Prophylactic Abdominal Drainage Tubes After Laparoscopic Distal Gastrectomy For Gastric Cancer
NCT ID: NCT07029269
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
454 participants
INTERVENTIONAL
2025-06-16
2028-09-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Zuoyi Jiao
OTHER
Responsible Party
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Zuoyi Jiao
Medical Professor
Locations
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International Hospital of Pecking University
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Sun Yat-sen University Cancer Center Gansu Hospital
Lanzhou, Gansu, China
Zhejiang Cancer Hospital
Zhejiang, Hangzhou, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Xi'an City, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LanzhouU2H-2025A-540
Identifier Type: -
Identifier Source: org_study_id