Feasibility of Enhanced Recovery After Surgery Without Prophylactic Abdominal Drainage Tub
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-tubele
| Condition(s) | Gastric Adenocarcinoma, Laparoscopic Gastrectomy, Complications |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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) p |
| Who can participate | 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 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Zuoyi Jiao |
| Locations | Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Lanzhou, Gansu, China; Lanzhou, Gansu, China; Zhejiang, Hangzhou, China; Xi'an, Xi'an City, China |
| Start date | 2025-06-16 |
| NCT ID | NCT07029269 |
| Official listing | https://clinicaltrials.gov/study/NCT07029269 |