Multi-institutional Study on the Assessment of Robotic Surgery for Gastric Cancer (NCT01309256) | Clinical Trial Compass
CompletedNot Applicable
Multi-institutional Study on the Assessment of Robotic Surgery for Gastric Cancer
South Korea1,650 participantsStarted 2011-03
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Registration of all robotic gastrectomies performed in South Korea
Timeframe: at the end of the study
2
Learning curve (operation time and surgical outcome) of robotic gastrectomy
Timeframe: from the start of the operation to discharge of the patient (usually two weeks after the operation)
3
Cost-effectiveness comparison between robotic and laparoscopic gastrectomy
Timeframe: from admission to discharge of the patient (usually from two days before the operation until two weeks after the operation)
4
Quality of life after robotic and laparoscopic gastrectomy
Timeframe: One day before operation, first OPD visit after the operation (two weeks after the operation), 3M, 12M, 36M, and 60M after the operation
5
Acute-inflammatory response after undergoing robotic and laparoscopic gastrectomy
Timeframe: preop, 2hr, 24hr, 4days and 30 days after the operation