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

wei bo

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Gastric Cancer

Treatments: Procedure: Laparoscopic-assisted Gastrectomy(LAG); Procedure: Robotic-assisted Gastrectomy(RAG)

Study type: Interventional

Funder types: Other

Identifiers

NCT02413476

sample20152018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Robotic-assisted Gastrectomy(RAG)

Experimental group

Description:

Robotic-assisted Gastrectomy will be performed for the treatment of patients assigned to this group.

Treatment:

Procedure: Robotic-assisted Gastrectomy(RAG)

Laparoscopic-assisted Gastrectomy(LAG)

Active Comparator group

Description:

Laparoscopic-assisted Gastrectomy will be performed for the treatment of patients assigned to this group.

Treatment:

Procedure: Laparoscopic-assisted Gastrectomy(LAG)