Korea Surgical Quality Improvement Program

Cholecystectomy Clinical Trial

— KSQIP  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02983474
• Other study ID #: NH16-007
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 1, 2016
• Last updated: December 7, 2016
• Start date: October 2016
• Est. completion date: June 2017

Study information

• Verified date: December 2016
• Source: National Evidence-Based Healthcare Collaborating Agency
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3000
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cholecystectomy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Evidence-Based Healthcare Collaborating Agency

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of bile leakage and iatrogenic duct injury		1 month	No