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

May 17, 2015 updated by: wei bo

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Five-year disease free survival rate
Time Frame: Up to 5 years post-operative
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 Frame: 7 days
time to first ambulation,flatus,liquid diet and soft diet,post-operative stay
7 days
Complication (score based on the Clavien-Dindo classification system)
Time Frame: 30 days
Compare the incidence,type and severity of early complications after gastrectomy,score based on the Clavien-Dindo classification system.
30 days
Mortality
Time Frame: 30 days
Measured as 30-day mortality rate
30 days
Hospitalization expenses
Time Frame: 30 days
the cost from admission to discharge
30 days
Quality of life
Time Frame: 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.
Up to 5 years post-operative
Five-year overall survival rate
Time Frame: Up to 5 years post-operative
Up to 5 years post-operative
Readmissions and recurrence rate
Time Frame: Up to 5 years post-operative
The number of postoperative readmissions and recurrence rate.
Up to 5 years post-operative
Operating time
Time Frame: 1 day
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)
Time Frame: 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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

wei bo

Investigators

  • Study Chair: Wei bo, MD, Vice director of the general surgery department, Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 9, 2015

First Posted (Estimate)

April 10, 2015

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 17, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sample20152018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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