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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT01309256

Collaborator

(none)

1,650

Enrollment

Location

23.1

Duration (Months)

71.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer

Study Design

Study Type:

Observational

Actual Enrollment :

1650 participants

Observational Model:

Cohort

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
R-robot group retrospective robot group
P-robot group prospective robot group
P-laparoscopic group prospective laparoscopic group

Outcome Measures

Primary Outcome Measures

Registration of all robotic gastrectomies performed in South Korea [at the end of the study]
Learning curve (operation time and surgical outcome) of robotic gastrectomy [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 [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 [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 [preop, 2hr, 24hr, 4days and 30 days after the operation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria for prospective study participants

Patients must have documented diagnosis of gastric cancer
Patients receiving laparoscopic gastric cancer surgery without preoperative evidence of serosal invasion and distant lymph node metastasis as determined by preoperative CT-scan, upper endoscopy, and endoscopic ultrasound.
Patients who have received comprehensive explanation about the planned study, understand and accept all the terms of the study and willingly give consent to participate in all the required elements of the study

Inclusion Criteria for retrospective study participants