Korea Surgical Quality Improvement Program

NCT02983474 | Unknown DMC

• 1 other identifier: NH16-007
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Composite of bile leakage and iatrogenic duct injury

  1 month

Interventions

cholecystectomy PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient who underwent cholecystectomy with cholecystitis or gallbladder polyp or cholelithiasis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Evidence-Based Healthcare Collaborating Agency: lead

MeSH Terms

Interventions

Cholecystectomy

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 6, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 8, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share