Multi-institutional Study on the Assessment of Robotic Surgery for Gastric Cancer
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ClinicalTrials.gov Identifier: NCT01309256 |
Recruitment Status
:
Completed
First Posted
: March 7, 2011
Last Update Posted
: June 4, 2013
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Sponsor:
Yonsei University
Information provided by (Responsible Party):
Yonsei University
Tracking Information | |||
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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 |
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Original Primary Outcome Measures |
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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 |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status | Completed | ||
Actual Enrollment |
1650 | ||
Original Estimated Enrollment |
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
Inclusion Criteria for retrospective study participants - Any patients who underwent robotic gastrectomy in Korea Exclusion Criteria for prospective study participants
Exclusion Criteria for retrospective study participants |
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Sex/Gender |
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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 |