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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01309256
Enrollment
1650
Registered
2011-03-07
Start date
2011-03-31
Completion date
2013-02-28
Last updated
2013-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

distal gastrectomy, Robotic gastrectomy, registry, learning curve, cost-effectiveness, quality of life, acute inflammatory reaction, Robotic and laparoscopic surgery

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.

Interventions

None listed

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Registration of all robotic gastrectomies performed in South Koreaat the end of the study
Learning curve (operation time and surgical outcome) of robotic gastrectomyfrom the start of the operation to discharge of the patient (usually two weeks after the operation)
Cost-effectiveness comparison between robotic and laparoscopic gastrectomyfrom 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 gastrectomyOne 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 gastrectomypreop, 2hr, 24hr, 4days and 30 days after the operation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026