NCT02983474

Korea Surgical Quality Improvement Program

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: National Evidence-Based Healthcare Collaborating Agency · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholecystectomy

Interventions

Type	Name	Description
PROCEDURE	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

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-12-06
• Last updated: 2016-12-08