Korea Surgical Quality Improvement Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cholecystectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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cholecystectomy

Laparoscopic surgery

1. Reverse Trendelenburg position
2. Skin incision and trocar insertion
3. CO2 gas insufflation
4. Intra-abdominal inspection and gallbladder exposure
5. Gallbladder traction
6. Calot triangle exposure
7. Cystic artery and cystic duct isolation
8. Gallbladder bed dissection
9. Bleeding control
10. Gallbladder extraction
11. Trocar removal and wound closure

Open surgery

1. Supine position
2. Skin incision
3. Intra-abdominal inspection and gallbladder exposure

5\. Gallbladder traction 6. Calot triangle exposure 7. Cystic artery and cystic duct isolation 8. Gallbladder bed dissection 9. Gallbladder extraction 10. Bleeding control 11. Wound closure

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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NH16-007

Identifier Type: -

Identifier Source: org_study_id