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Clinical Trials/NCT01309256
NCT01309256
Completed
Not Applicable

Multi-institutional Study on the Assessment of Robotic Surgery for Gastric Cancer

Yonsei University1 site in 1 country1,650 target enrollmentMarch 2011
ConditionsGastric Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric Cancer
Sponsor
Yonsei University
Enrollment
1650
Locations
1
Primary Endpoint
Registration of all robotic gastrectomies performed in South Korea
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Minimally invasive surgery revolutionized the field of gastric cancer surgery. The surgical robot was introduced to alleviate the difficulty of laparoscopic surgery. Although many studies have reported successful outcomes for robotic surgery, there is no multicenter prospective analysis regarding the advantage of the robotic gastrectomy. The aim of this study is to analyze the surgical outcomes of the robotic gastrectomy focusing on the learning curve, cost-effectiveness, quality of life, and acute-inflammatory reaction in comparison with laparoscopic gastrectomy.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
February 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Registration of all robotic gastrectomies performed in South Korea

Time Frame: at the end of the study

Learning curve (operation time and surgical outcome) of robotic gastrectomy

Time Frame: from the start of the operation to discharge of the patient (usually two weeks after the operation)

Cost-effectiveness comparison between robotic and laparoscopic gastrectomy

Time Frame: from admission to discharge of the patient (usually from two days before the operation until two weeks after the operation)

Quality of life after robotic and laparoscopic gastrectomy

Time Frame: One day before operation, first OPD visit after the operation (two weeks after the operation), 3M, 12M, 36M, and 60M after the operation

Acute-inflammatory response after undergoing robotic and laparoscopic gastrectomy

Time Frame: preop, 2hr, 24hr, 4days and 30 days after the operation

Study Sites (1)

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