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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01309256
Recruitment Status : Completed
First Posted : March 7, 2011
Last Update Posted : June 4, 2013
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease
Gastric Cancer

Study Type : Observational
Actual Enrollment : 1650 participants
Observational Model: Cohort
Study Start Date : March 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

R-robot group
retrospective robot group
P-robot group
prospective robot group
P-laparoscopic group
prospective laparoscopic group

Primary Outcome Measures :
  1. Registration of all robotic gastrectomies performed in South Korea [ Time Frame: at the end of the study ]
  2. 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) ]
  3. 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) ]
  4. 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 ]
  5. Acute-inflammatory response after undergoing robotic and laparoscopic gastrectomy [ Time Frame: preop, 2hr, 24hr, 4days and 30 days after the operation ]

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Gastric cancer patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01309256

Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yonsei University Identifier: NCT01309256     History of Changes
Other Study ID Numbers: 4-2010-0659
First Posted: March 7, 2011    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: June 2013

Keywords provided by Yonsei University:
distal gastrectomy
Robotic gastrectomy
learning curve
quality of life
acute inflammatory reaction
Robotic and laparoscopic surgery

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases