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

• Conditions: Patients Who Underwent Gastrectomy With Lymph Node Dissection for Gastric Cancer
• Interventions: Procedure: gastrectomy

• Registration Number: NCT01919242
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-08-07
• Study First Submitted QC: 2013-08-07
• Study First Posted: 2013-08-08
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• patients who had histologically confirmed gastric cancer and are going to underwent gastrectomy
• age over 20 years with agree to the study

Read More

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)

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
with morbidity	gastrectomy	patients who suffered from any type of morbidity after surgery
without morbidity	gastrectomy	patients who did not suffer from any type of morbidity after surgery

Primary Outcome Measures

Name	Time	Method
the type of complications and the incidence of it	within 30 days after operation, any case of re-admission	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.

Trial Locations

Locations (1)

Department of Surgery, Yonsei University Health System, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of