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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Mar 7, 2011
Registry last updated: Jun 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed