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

Phase 2

• Conditions: Gastric Cancer
• Interventions: Procedure: Robotic-assisted Gastrectomy(RAG); Procedure: Laparoscopic-assisted Gastrectomy(LAG)

• Registration Number: NCT02413476
• Lead Sponsor: wei bo

Brief Summary

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

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.

Study Timeline

• Status Verified: 2015-04
• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-09
• Study First Posted: 2015-04-10
• Study Start: 2015-05
• Last Update Submitted: 2015-05-17
• Last Update Posted: 2015-05-19
• Primary Completion: 2018-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Pathologically proven gastric cancer(early or advanced).
2. Age:older than 18 years old,younger than 80 years old.
3. 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
4. No obvious surgical contraindications.
5. American Society of Anesthesiology (ASA) score class I, II, or III
6. Written informed consent.

Exclusion Criteria

1. Severe mental disorder
2. Pregnancy
3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
4. History of previous gastrectomy,endoscopic mucosal resection or endoscopic submucosal dissection.
5. History of unstable angina or myocardial infarction within past six months
6. History of previous neoadjuvant chemotherapy or radiotherapy
7. History of other malignant disease within past 5 years.
8. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
9. Any accompanying surgical condition needed to be performed in the same time

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic-assisted Gastrectomy(RAG)	Robotic-assisted Gastrectomy(RAG)	Robotic-assisted Gastrectomy will be performed for the treatment of patients assigned to this group.
Laparoscopic-assisted Gastrectomy(LAG)	Laparoscopic-assisted Gastrectomy(LAG)	Laparoscopic-assisted Gastrectomy will be performed for the treatment of patients assigned to this group.

Primary Outcome Measures

Name	Time	Method
Five-year disease free survival rate	Up to 5 years post-operative

Secondary Outcome Measures

Name	Time	Method
Postoperative recovery course (time to first ambulation,flatus,liquid diet and soft diet,post-operative stay)	7 days	time to first ambulation,flatus,liquid diet and soft diet,post-operative stay
Mortality	30 days	Measured as 30-day mortality rate
Operating time	1 day	The operating time was defined as the time from skin incision to wound closure.
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)	1 day	The number of lymph node dissection,the number of positive lymph nodes,extra-cavity anastomosis time,intraoperative blood loss,the rate of conversion
Complication (score based on the Clavien-Dindo classification system)	30 days	Compare the incidence,type and severity of early complications after gastrectomy,score based on the Clavien-Dindo classification system.
Hospitalization expenses	30 days	the cost from admission to discharge
Quality of life	Up to 5 years post-operative	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.
Five-year overall survival rate	Up to 5 years post-operative
Readmissions and recurrence rate	Up to 5 years post-operative	The number of postoperative readmissions and recurrence rate.