Clinical Outcomes of Robotic Versus Laparoscopic Distal Gastrectomy for Gastric Cancer
- Conditions
- Robotic SurgeryStomach Neoplasm
- Interventions
- Procedure: Laparoscopic Distal GastrectomyProcedure: Robotic Distal Gastrectomy
- Registration Number
- NCT03313700
- Lead Sponsor
- Fujian Medical University
- 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）.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Age from over 18 to under 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- cT1-4a(clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- expected to perform distal gastrectomy with D1+/D2 lymph node dissction to obtain R0 resection sugicall results.
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) class I to III
- Written informed consent
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
- Gastric multiple primary carcinoma
- Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
- History of other malignant disease within the past 5 years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within the past 6 months
- History of cerebrovascular accident within the past 6 months
- History of continuous systematic administration of corticosteroids within 1 month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of the predicted values
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Laparoscopic Distal Gastrectomy Laparoscopic Distal Gastrectomy Laparoscopic Distal Gastrectomy will be performed for the treatment of patients assigned to this group. Robotic Distal Gastrectomy Robotic Distal Gastrectomy Robotic Distal Gastrectomy will be performed for the treatment of patients assigned to this group.
- Primary Outcome Measures
Name Time Method 3-year disease free survival rate 36 months the rate of 3-year disease free survival
- Secondary Outcome Measures
Name Time Method Hospitalization expenses 30 days The cost from admission to discharge
operation time 1 days operation time
the noncompliance rate of lymphadenectomy 1 days the noncompliance rate of lymphadenectomy
3-year overall survival rate 36 months the rate of 3-year overall survival rate
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
Time to first flatus 30 days Time to first flatus in days is used to assess the postoperative recovery course.
Time to first soft diet 30 days Time to first soft diet in days is used to assess the postoperative recovery course.
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 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.
Time to first ambulation 30 days Time to first ambulation in hours 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.
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 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.
Trial Locations
- Locations (1)
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China