Patients Who Underwent Gastrectomy With Lymph Node Dissection for Gastric Cancer Clinical Trial
| NCT number | NCT01919242 |
| Other study ID # | 4-2012-0800 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2013 |
| Est. completion date | September 2023 |
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.
| Status | Recruiting |
| Enrollment | 10000 |
| Est. completion date | September 2023 |
| Est. primary completion date | September 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 90 Years |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Department of Surgery, Yonsei University Health System, Yonsei University College of Medicine | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
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* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | the type of complications and the incidence of it | the 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. | within 30 days after operation, any case of re-admission |