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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01309256
First received: March 4, 2011
Last updated: June 1, 2013
Last verified: June 2013
History of Changes

March 4, 2011
June 1, 2013
March 2011
February 2013   (Final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT01309256 on ClinicalTrials.gov Archive Site
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Multi-institutional Study on the Assessment of Robotic Surgery for Gastric Cancer
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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.
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Observational
Observational Model: Cohort
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Non-Probability Sample
Gastric cancer patients
Gastric Cancer
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  • R-robot group
    retrospective robot group
  • P-robot group
    prospective robot group
  • P-laparoscopic group
    prospective laparoscopic group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1650
February 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01309256
4-2010-0659
Yes
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Yonsei University
Yonsei University
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Yonsei University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP