Gastrectomy, Laparoscopy
Conditions
Keywords
Laparoscopy-assisted Gastrectomy, Gastric cancer
Brief summary
The aim of this trial is to confirm the non-inferiority of Gasless laparoscopy-assisted distal D2 radical gastrectomy to the conventional laparoscopy-assisted distal D2 radical gastrectomy for the treatment of advanced gastric cancer patients (T2-4a, N0-3, M0).
Detailed description
The primary end point was operative time for Gasless laparoscopy-assisted distal D2 radical gastrectomy and conventional laparoscopy-assisted distal D2 radical gastrectomy. The secondary outcomes of interest were intraoperative vital signs; postoperative pain; and surgeon satisfaction for D2 radical gastrectomy.
Interventions
DEVICEConventional Laparoscopy
A procedure in which a laparoscope (LAPAROSCOPES) is inserted through a small incision near the navel to examine the abdominal and pelvic organs in the PERITONEAL CAVITY using Induced pneumoperitoneum.
DEVICEGasless Laparoscopy
A procedure in which a laparoscope (LAPAROSCOPES) is inserted through a small incision near the navel to examine the abdominal and pelvic organs in the PERITONEAL CAVITY without Induced pneumoperitoneum.It mechanically elevates the abdominal wall and allows laparoscopic visualization through a single incision, providing diagnostic and therapeutic procedures.
Sponsors
Xue Yingwei
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age \>18 and \<75 years old; 2. The gastric primary lesion is diagnosed as gastric adenocarcinoma by endoscopic biopsy histopathologic techniques (papillary adenocarcinoma \[pap\], tubular adenocarcinoma \[tub\], mucinous adenocarcinoma \[muc\], signet ring cell carcinoma \[sig\], and poorly differentiated adenocarcinoma \[por\]); 3. Preoperative clinical staging of T2-4a, N0-3, M0 (see preoperative assessment program; tumor staging is in accordance with AJCC-7th TNM); 4. It is expected that R0 surgical results will be obtained by distal subtotal gastrectomy and D2 lymph node dissection (also applies to multiple primary tumors) 5. Preoperative ECOG status score of 0/1; 6. Preoperative ASA (American society of anesthesiology) class of I -III; 7. Patients signed informed consent.
Exclusion criteria
1. Pregnant or lactating women; 2. Serious mental illness; 3. History of abdominal surgery (except for laparoscopic cholecystectomy); 4. History of gastric surgery (including ESD/EMR for gastric cancer); 5. Preoperative imaging examination suggests regional integration enlargement of lymph nodes (maximum diameter ≥3 cm) 6. Other malignant disease history within five (5) years; 7. Patients who received or were recommended a new adjuvant therapy; 8. History of unstable angina or myocardial infarction within six (6) months; 9. History of cerebral infarction or cerebral hemorrhage within six (6) months; 10. History of sustained systemic corticosteroid therapy within one (1) month; 11. Patients requiring simultaneous surgical treatment of other diseases; 12. Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery; 13. Pulmonary function test with FEV1 \<50% of the expected value.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | During procedure. | The primary end point was operative time for Gasless Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy and conventional Laparoscopy-assisted Gastrectomy with D2 Lymphadenectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| End-tidal carbon dioxide | Through study completion, an average of 2 year. | Intraoperative end-tidal carbon dioxide |
| Heart rate | Through study completion, an average of 2 year. | Intraoperative heart rate |
| Estimated blood loss | Through study completion, an average of 2 year. | Intraoperative estimated blood loss |
| Blood pressure | Through study completion, an average of 2 year. | Intraoperative blood pressure |
| Death | Through study completion, an average of 2 year. | Intraoperative death |
| Blood transfusion | Through study completion, an average of 2 year. | Intraoperative and postoperative blood transfusion |
| Tumor size | Through study completion, an average of 2 year. | Tumor size |
| Complications | Through study completion, an average of 2 year. | Intraoperative complications |
Countries
China
Outcome results
None listed