Korea Surgical Quality Improvement Program

Overview

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.

Full Title of Study: “Development of Cholecystectomy Complication Predictive Model for Developing the Surgical Quality Improvement Program”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2017

Interventions

  • Procedure: cholecystectomy
    • Laparoscopic surgery Reverse Trendelenburg position Skin incision and trocar insertion CO2 gas insufflation Intra-abdominal inspection and gallbladder exposure Gallbladder traction Calot triangle exposure Cystic artery and cystic duct isolation Gallbladder bed dissection Bleeding control Gallbladder extraction Trocar removal and wound closure Open surgery Supine position Skin incision 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

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Evidence-Based Healthcare Collaborating Agency
  • Provider of Information About this Clinical Study
    • Sponsor

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