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Postoperative Morbidity and Mortality After Gastrectomy for Gastric Cancer: Prospective Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01919242
Enrollment
10000
Registered
2013-08-08
Start date
2013-01-31
Completion date
2023-09-30
Last updated
2019-01-11

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

Conditions

Patients Who Underwent Gastrectomy With Lymph Node Dissection for Gastric Cancer

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.

Interventions

PROCEDUREgastrectomy

gastrectomy with D1 + lymph node dissection for clinically early gastric cancer, and gastrectomy with D2 lymph node dissection for clinically advanced gastric cancer

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
the type of complications and the incidence of itwithin 30 days after operation, any case of re-admissionthe types of complication is classified into as follows: wound complications, intra-abdominal fluid collection or abscess, intra-luminal bleeding, intra-abdominal bleeding, intestinal obstruction, ileus, stricture of anastomosis, anastomosis leak, pancreatitis, pulmonary complications, urinary tract infection, renal dysfunction, hepatic dysfunction, cardiac dysfunction, endocrine dysfunction, miscellaneous complications. Each complication will be graded according to Clavian-Dindo classification. Re-admission or visiting emergency room will be checked and recorded.

Countries

South Korea

Contacts

Primary ContactWoo Jin Hyung, MD
wjhyung@yuhs.ac82-2-2228-2100

Outcome results

None listed

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