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
  Purpose

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
Gastric Cancer

Study Type: Observational
Study Design: Observational Model: Cohort

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Registration of all robotic gastrectomies performed in South Korea [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Acute-inflammatory response after undergoing robotic and laparoscopic gastrectomy [ Time Frame: preop, 2hr, 24hr, 4days and 30 days after the operation ] [ Designated as safety issue: No ]

Enrollment: 1650
Study Start Date: March 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
R-robot group
retrospective robot group
P-robot group
prospective robot group
P-laparoscopic group
prospective laparoscopic group

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Gastric cancer patients

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309256

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

Publications:

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01309256     History of Changes
Other Study ID Numbers: 4-2010-0659
Study First Received: March 4, 2011
Last Updated: June 1, 2013
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

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

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

ClinicalTrials.gov processed this record on October 30, 2014