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 range20 Years

SexALL

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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

What they're measuring

Registration of all robotic gastrectomies performed in South Korea

Timeframe: at the end of the study

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)

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)

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

Acute-inflammatory response after undergoing robotic and laparoscopic gastrectomy

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

Trial details

NCT IDNCT01309256

SponsorYonsei University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-02

View on ClinicalTrials.gov More Gastric Cancer trials