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

Study Overview
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Brief Summary
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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.

Conditions
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Gastric Cancer

Participation Criteria
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Eligibility Criteria
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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 - Any patients who underwent robotic gastrectomy in Korea Exclusion Criteria for prospective study participants Patients without mental competence Patients who are illiterate Patients who are pregnant Patients < 20 years old Exclusion Criteria for retrospective study participants

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| R-robot group<br>retrospective robot group | |
| P-robot group<br>prospective robot group | |
| P-laparoscopic group<br>prospective laparoscopic group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distal gastrectomy, Robotic gastrectomy, registry, learning curve, cost-effectiveness, quality of life, acute inflammatory reaction, Robotic and laparoscopic surgery