Korea Surgical Quality Improvement Program

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02983474

Acronym

KSQIP

Enrollment

3000

Registered

2016-12-06

Start date

2016-10-31

Completion date

2017-06-30

Last updated

2016-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystectomy

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.

Interventions

PROCEDUREcholecystectomy

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Composite of bile leakage and iatrogenic duct injury	1 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026