Clinical trial NCT01919242: Postoperative Morbidity and Mortality After Gastrectomy for Gastric Cancer: Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Who Underwent Gastrectomy With Lymph Node Dissection for Gastric Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-08-08
Enrollment: 10000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent gastrectomy with lymph node dissection for gastric cancer in Yonsei University Hospital, Seoul

Brief 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.


Eligibility 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)

Primary outcomes:
measure: the type of complications and the incidence of it
timeFrame: within 30 days after operation, any case of re-admission
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Yonsei University Health System, Yonsei University College of Medicine
Study officials:
References:
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