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

January 10, 2019 updated by: Yonsei University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Woo Jin Hyung, MD
  • Phone Number: 82-2-2228-2100
  • Email: wjhyung@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Department of Surgery, Yonsei University Health System, Yonsei University College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients who underwent gastrectomy with lymph node dissection for gastric cancer in Yonsei University Hospital, Seoul

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
with morbidity
patients who suffered from any type of morbidity after surgery
Procedure: gastrectomy
gastrectomy with D1 + lymph node dissection for clinically early gastric cancer, and gastrectomy with D2 lymph node dissection for clinically advanced gastric cancer
without morbidity
patients who did not suffer from any type of morbidity after surgery
Procedure: gastrectomy
gastrectomy with D1 + lymph node dissection for clinically early gastric cancer, and gastrectomy with D2 lymph node dissection for clinically advanced gastric cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the type of complications and the incidence of it
Time Frame: 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.
within 30 days after operation, any case of re-admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

August 7, 2013

First Submitted That Met QC Criteria

August 7, 2013

First Posted (Estimate)

August 8, 2013

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2012-0800

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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