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

Tracking Information
First Submitted Date	March 4, 2011
First Posted Date	March 7, 2011
Last Update Posted Date	June 4, 2013
Study Start Date	March 2011
Actual Primary Completion Date	February 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: May 26, 2011)	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 ]
Original Primary Outcome Measures; (submitted: March 4, 2011)	Registration of all robotic gastrectomies performed in South Korea [ Time Frame: end of the study (May, 31, 2013) ]; 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 ]
Change History	Complete list of historical versions of study NCT01309256 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Multi-institutional Study on the Assessment of Robotic Surgery for Gastric Cancer
Official Title	Not Provided
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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Gastric cancer patients
Condition	Gastric Cancer
Intervention	Not Provided
Study Groups/Cohorts	R-robot group retrospective robot group; P-robot group prospective robot group; P-laparoscopic group prospective laparoscopic group
Publications *	Song J, Oh SJ, Kang WH, Hyung WJ, Choi SH, Noh SH. Robot-assisted gastrectomy with lymph node dissection for gastric cancer: lessons learned from an initial 100 consecutive procedures. Ann Surg. 2009 Jun;249(6):927-32. doi: 10.1097/01.sla.0000351688.64999.73.; Song J, Kang WH, Oh SJ, Hyung WJ, Choi SH, Noh SH. Role of robotic gastrectomy using da Vinci system compared with laparoscopic gastrectomy: initial experience of 20 consecutive cases. Surg Endosc. 2009 Jun;23(6):1204-11. doi: 10.1007/s00464-009-0351-4. Epub 2009 Mar 5.; Kim MC, Heo GU, Jung GJ. Robotic gastrectomy for gastric cancer: surgical techniques and clinical merits. Surg Endosc. 2010 Mar;24(3):610-5. doi: 10.1007/s00464-009-0618-9. Epub 2009 Aug 18.; Song J, Lee HJ, Cho GS, Han SU, Kim MC, Ryu SW, Kim W, Song KY, Kim HH, Hyung WJ; Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) Group. Recurrence following laparoscopy-assisted gastrectomy for gastric cancer: a multicenter retrospective analysis of 1,417 patients. Ann Surg Oncol. 2010 Jul;17(7):1777-86. doi: 10.1245/s10434-010-0932-4. Epub 2010 Feb 12.; Lee HJ, Kim HH, Kim MC, Ryu SY, Kim W, Song KY, Cho GS, Han SU, Hyung WJ, Ryu SW; Korean Laparoscopic Gastrointestinal Surgery Study Group. The impact of a high body mass index on laparoscopy assisted gastrectomy for gastric cancer. Surg Endosc. 2009 Nov;23(11):2473-9. doi: 10.1007/s00464-009-0419-1. Epub 2009 Apr 3.; Kim MC, Kim W, Kim HH, Ryu SW, Ryu SY, Song KY, Lee HJ, Cho GS, Han SU, Hyung WJ; Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) Group. Risk factors associated with complication following laparoscopy-assisted gastrectomy for gastric cancer: a large-scale korean multicenter study. Ann Surg Oncol. 2008 Oct;15(10):2692-700. doi: 10.1245/s10434-008-0075-z. Epub 2008 Jul 29.; Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b.; Kim HI, Han SU, Yang HK, Kim YW, Lee HJ, Ryu KW, Park JM, An JY, Kim MC, Park S, Song KY, Oh SJ, Kong SH, Suh BJ, Yang DH, Ha TK, Kim YN, Hyung WJ. Multicenter Prospective Comparative Study of Robotic Versus Laparoscopic Gastrectomy for Gastric Adenocarcinoma. Ann Surg. 2016 Jan;263(1):103-9. doi: 10.1097/SLA.0000000000001249.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: June 1, 2013)	1650
Original Estimated Enrollment; (submitted: March 4, 2011)	1700
Actual Study Completion Date	February 2013
Actual Primary Completion Date	February 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria	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
Sex/Gender	Sexes Eligible for Study: All
Ages	20 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Korea, Republic of
Removed Location Countries
Administrative Information
NCT Number	NCT01309256
Other Study ID Numbers	4-2010-0659
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Yonsei University
Study Sponsor	Yonsei University
Collaborators	Not Provided
Investigators	Not Provided
PRS Account	Yonsei University
Verification Date	June 2013