CholecystectomyKSQIPNCT02983474
Korea Surgical Quality Improvement Program
An observational study of Cholecystectomy, run by National Evidence-Based Healthcare Collaborating Agency.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystectomy
- What is being tested?
- cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Jun 2017
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient who underwent cholecystectomy with cholecystitis or gallbladder polyp or cholelithiasis
Who may be able to join
- Patient who underwent cholecystectomy with cholecystitis or gallbladder polyp or cholelithiasis
Who cannot join
- Under 18 age
- Who underwent other abdominal surgery simultaneously
- Gallbladder Cancer, cholangiocarcinoma
- Who did not agree with participation
About this study
Official title: Development of Cholecystectomy Complication Predictive Model for Developing the Surgical Quality Improvement Program
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
- Being tested
- cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecystectomyProcedure or surgery
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
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of bile leakage and iatrogenic duct injury
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- National Evidence-Based Healthcare Collaborating Agency
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983474
- Sponsor's protocol ID
- NH16-007
- Acronym
- KSQIP
- Status last verified
- Dec 2016
- First submitted
- 1 Dec 2016
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Cholecystectomy Complication Predictive Model for Developing the Surgical Quality Improvement Program
- ClinicalTrials.gov ID
- NCT02983474
- Acronym / sponsor ID
- KSQIP / NH16-007
- Conditions
- Cholecystectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- National Evidence-Based Healthcare Collaborating AgencyOther government
- Study start
- Oct 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient who underwent cholecystectomy with cholecystitis or gallbladder polyp or cholelithiasis
Key inclusion criteria (1 listed)
- Patient who underwent cholecystectomy with cholecystitis or gallbladder polyp or cholelithiasis
Key exclusion criteria (4 listed)
- Under 18 age
- Who underwent other abdominal surgery simultaneously
- Gallbladder Cancer, cholangiocarcinoma
- Who did not agree with participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cholecystectomyLaparoscopic 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 | Procedure or surgery | – |
Primary outcome
Composite of bile leakage and iatrogenic duct injury
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystectomy, run by National Evidence-Based Healthcare Collaborating Agency.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of bile leakage and iatrogenic duct injury (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2016.