Korea Surgical Quality Improvement Program (KSQIP)

December 7, 2016 updated by: National Evidence-Based Healthcare Collaborating Agency

Development of Cholecystectomy Complication Predictive Model for Developing the Surgical Quality Improvement Program

The member of National Evidence-based Healthcare Collaborating Agency and the planning committee of Korean Association of hepato-biliary pancreatic Surgery established the protocol of Korean Surgical Quality Improvement Program (KSQIP) with verifying variables of American College of Surgeons - National Surgical Quality Improvement Program (ACS-NSQIP and National Clinical Database (NCD) of Japan; demographics, preoperative information, laboratory values, operation finding, general occurrences, postoperative occurrences, and follow-up data to develop post cholecystectomy complication risk model.

The 50 surgeons from 20 hospitals have decided to participated in the primary prospective study to apply KSQIP to cholecystectomy. The investigators developed web-based database system (http://www.ksqip.org/gb) and surgical clinical reviewer of each hospital will fill out the case report form. Finally, the investigators will provide a risk-adjusted surgical risk calculator and feedback system for reducing complication.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

3000

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patient who underwent cholecystectomy with cholecystitis or gallbladder polyp or cholelithiasis

Description

Inclusion Criteria:

  • Patient who underwent cholecystectomy with cholecystitis or gallbladder polyp or cholelithiasis

Exclusion Criteria:

  • Under 18 age
  • Who underwent other abdominal surgery simultaneously
  • Gallbladder Cancer, cholangiocarcinoma
  • Who did not agree with participation

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of bile leakage and iatrogenic duct injury
Time Frame: 1 month
1 month

Collaborators and Investigators

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

Sponsor

National Evidence-Based Healthcare Collaborating Agency

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

October 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (Estimate)

December 6, 2016

Study Record Updates

Last Update Posted (Estimate)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • NH16-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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