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Trial Title:
Postoperative Morbidity and Mortality After Gastrectomy for Gastric Cancer: Prospective Cohort Study
NCT ID:
NCT01919242
Condition:
Patients Who Underwent Gastrectomy With Lymph Node Dissection for Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
gastrectomy
Description:
gastrectomy with D1 + lymph node dissection for clinically early gastric cancer, and
gastrectomy with D2 lymph node dissection for clinically advanced gastric cancer
Arm group label:
with morbidity
Arm group label:
without morbidity
Summary:
Gastric cancer is still one of the main health care issue and gastrectomy with lymph node
dissection is the only chance to be cure. Even though the development and standardization
of gastric cancer surgery, the morbidity of gastric cancer surgery was reported around
20% with less than 1% of mortality in East. In contrast, around 40% of morbidity and 10%
of mortality was reported in West. There has been several indexes which can define the
complications after surgery, but adapting it into clinical practice is sometimes
difficult due to the heterogeneous opinion between surgeons. Thus for clear defining the
complications after surgery, consensus between many surgeons and prospective cohort study
is necessary. The purpose of this study is collecting the complications data after
gastric cancer surgery and defining it with every week meeting by at least 6 or more
surgeons' discussion.
Criteria for eligibility:
Study pop:
patients who underwent gastrectomy with lymph node dissection for gastric cancer in
Yonsei University Hospital, Seoul
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- patients who had histologically confirmed gastric cancer and are going to underwent
gastrectomy
- age over 20 years with agree to the study
Exclusion Criteria:
- withdrawal of their agreement
- vulnerable subjects (ex. pregnancy, disabled to decide by him or herself, cannot
understand the study such as mental retardation or foreigner)
Gender:
All
Minimum age:
20 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Surgery, Yonsei University Health System, Yonsei University College of Medicine
Address:
City:
Seoul
Zip:
120-752
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Woo Jin Hyung, MD
Phone:
82-2-2228-2100
Email:
wjhyung@yuhs.ac
Start date:
January 2013
Completion date:
September 2023
Lead sponsor:
Agency:
Yonsei University
Agency class:
Other
Source:
Yonsei University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01919242
