Robotic Surgery, Stomach Neoplasm
Conditions
Keywords
Stomach Neoplasm, Robotic Surgery, Distal Gastrectomy
Brief summary
The purpose of this study is to explore the clinical outcomes of the robotic distal gastrectomy for patients with gastric adenocarcinoma（cT1-4a, N-/+, M0）.
Detailed description
Robotic surgery has been developed with the aim of improving surgical quality and overcoming the limitations of conventional laparoscopy in the performance of complex mini-invasive procedures. The study is designed to explore the clinical outcomes of the robotic distal gastrectomy by comparing short- and long-term outcomes including financial cost of robotic and laparoscopic distal gastrectomy in the treatment of gastric adenocarcinoma （cT1-4a, N-/+, M0）.
Interventions
PROCEDURERobotic Distal Gastrectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case, robotic distal gastrectomy will be performed in the experimental group.
PROCEDURELaparoscopic Distal Gastrectomy
After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic distal gastrectomy will be performed in the comparator group.
Sponsors
Fujian Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age from over 18 to under 75 years 2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy 3. cT1-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition 4. expected to perform distal gastrectomy with D1+/D2 lymph node dissction to obtain R0 resection sugicall results. 5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale 6. ASA (American Society of Anesthesiology) class I to III 7. Written informed consent
Exclusion criteria
1. Women during pregnancy or breast-feeding 2. Severe mental disorder 3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy) 4. History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer) 5. Gastric multiple primary carcinoma 6. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging 7. History of other malignant disease within the past 5 years 8. History of previous neoadjuvant chemotherapy or radiotherapy 9. History of unstable angina or myocardial infarction within the past 6 months 10. History of cerebrovascular accident within the past 6 months 11. History of continuous systematic administration of corticosteroids within 1 month 12. Requirement of simultaneous surgery for other disease 13. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer 14. FEV1\<50% of the predicted values
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-year disease free survival rate | 36 months | the rate of 3-year disease free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year recurrence pattern | 36 months | the pattern of recurrence in 3 years |
| overall postoperative morbidity rates | 30 days | Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery. |
| intraoperative morbidity rates | 1 day | The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation. |
| overall postoperative serious morbidity rates | 30 days | Refers to the incidence of early postoperative complication which is graded as Clavien-Dindo IIIA or higher |
| number of retrieved lymph nodes | 1 days | number of retrieved lymph nodes |
| the noncompliance rate of lymphadenectomy | 1 days | the noncompliance rate of lymphadenectomy |
| Time to first ambulation | 30 days | Time to first ambulation in hours is used to assess the postoperative recovery course. |
| Time to first flatus | 30 days | Time to first flatus in days is used to assess the postoperative recovery course. |
| Time to first liquid diet | 30 days | Time to first liquid diet in days is used to assess the postoperative recovery course. |
| 3-year overall survival rate | 36 months | the rate of 3-year overall survival rate |
| Duration of postoperative hospital stay | 30 days | Duration of postoperative hospital stay in days is used to assess the postoperative recovery course. |
| The variation of weight | 3, 6, 9 and 12 months | The variation of weight in kilograms on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status. |
| The variation of cholesterol | 3, 6, 9 and 12 months | The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status. |
| The variation of album | 3, 6, 9 and 12 months | The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status. |
| The variation of white blood cell count | Preoperative 7 days and postoperative 1 and 5 days | The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 5 are recorded to access the inflammatory response. |
| The variation of hemoglobin | Preoperative 7 days and postoperative 1 and 5 days | The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 5 are recorded to access the inflammatory response. |
| Hospitalization expenses | 30 days | The cost from admission to discharge |
| operation time | 1 days | operation time |
| Time to first soft diet | 30 days | Time to first soft diet in days is used to assess the postoperative recovery course. |
Countries
China
Outcome results
None listed