Comparison of Surgical,Clinical and Oncological Outcomes Between Robotic-assisted and Laparoscopic-assisted Gastrectomy

Study Overview
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Brief Summary
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The study aims to compare the clinical outcomes between robotic-assisted and laparoscopic-assisted gastrectomy for gastric cancer,and evaluate the the feasibility and safety of robotic gastrectomy. Furthermore, the investigators can explore the patients who are more suitable for robotic gastrectomy.

Detailed Description
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This is a prospective study lasting 36 months. Minimally invasive gastrectomy is accepted widely in Asian countries. Laparoscopic-assisted gastrectomy offers improved early postoperative outcomes and improved long-term oncologic outcomes,but it still has its own limitations.The advantages of robotic surgery include a 3D imagine, convenient movements of the robotic arm, no tremor, and ambidextrous capability. This study therefore aimed to compare the clinical results between robotic-assisted gastrectomy(RAG) using the da Vinci Surgical System and conventional laparoscopic-assisted gastrectomy(LAG) in gastric cancer patients.To evaluate the the feasibility and safety of robotic gastrectomy and explore the patients who are more suitable for robotic gastrectomy.

Official Title
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Compared With Robotic-assisted and Laparoscopic-assisted Gastrectomy for Gastric Cancer on Surgical,Clinical and Oncological Outcomes

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Robotic-assisted Gastrectomy(RAG)
* Procedure: Laparoscopic-assisted Gastrectomy(LAG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically proven gastric cancer(early or advanced). Age:older than 18 years old,younger than 80 years old. cT1-4a(surgically resectable tumor),N0-3,M0 at preoperative evaluation according to the American Joint Committee on Cancer(AJCC) Cancer Staging Manual Seventh Edition No obvious surgical contraindications. American Society of Anesthesiology (ASA) score class I, II, or III Written informed consent. Exclusion Criteria: Severe mental disorder Pregnancy History of previous upper abdominal surgery (except laparoscopic cholecystectomy) History of previous gastrectomy,endoscopic mucosal resection or endoscopic submucosal dissection. History of unstable angina or myocardial infarction within past six months History of previous neoadjuvant chemotherapy or radiotherapy History of other malignant disease within past 5 years. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging Any accompanying surgical condition needed to be performed in the same time

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic-assisted Gastrectomy(RAG)<br>Robotic-assisted Gastrectomy will be performed for the treatment of patients assigned to this group. | Procedure: Robotic-assisted Gastrectomy(RAG)<br>* Surgical procedure will be performed with da vinci Surgical System.The type of reconstruction will be selected according to the surgeon's experience.<br>|
| Active Comparator: Laparoscopic-assisted Gastrectomy(LAG)<br>Laparoscopic-assisted Gastrectomy will be performed for the treatment of patients assigned to this group. | Procedure: Laparoscopic-assisted Gastrectomy(LAG)<br>* Surgical procedure will be performed with laparoscopic techniques.The type of reconstruction will be selected according to the surgeon's experience.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Five-year disease free survival rate |  | Up to 5 years post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative recovery course (time to first ambulation,flatus,liquid diet and soft diet,post-operative stay) | time to first ambulation,flatus,liquid diet and soft diet,post-operative stay | 7 days | 
| Complication (score based on the Clavien-Dindo classification system) | Compare the incidence,type and severity of early complications after gastrectomy,score based on the Clavien-Dindo classification system. | 30 days | 
| Mortality | Measured as 30-day mortality rate | 30 days | 
| Hospitalization expenses | the cost from admission to discharge | 30 days | 
| Quality of life | The validated quality of life questionnaires EORTC QLQ-30 will be filled in pre-operative <5 days and post-operative at 6, 12, 24, 36, 48 and 60 months after surgery. | Up to 5 years post-operative | 
| Five-year overall survival rate |  | Up to 5 years post-operative | 
| Readmissions and recurrence rate | The number of postoperative readmissions and recurrence rate. | Up to 5 years post-operative | 
| Operating time | The operating time was defined as the time from skin incision to wound closure. | 1 day | 
| Intraoperative situation (The number of lymph node dissection,the number of positive lymph nodes,extra-cavity anastomosis time,intraoperative blood loss,the rate of conversion) | The number of lymph node dissection,the number of positive lymph nodes,extra-cavity anastomosis time,intraoperative blood loss,the rate of conversion | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robotic-assisted gastrectomy, laparoscopic-assisted gastrectomy, gastric cancer