CholecystitisDutch CHESSNCT06349863
Dutch Cholecystitis Snapshot Study
An observational study of Cholecystitis and Cholecystitis; Gallstone, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
Background: Cholecystitis is treated by in various types of hospitals by different specialists, and treatment strategy is influenced by logistical and medical reasons and personal preference. This may significantly impact hospital stay and other outcomes. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cholecystitis, Cholecystitis; Gallstone, Cholecystitis; Choledocholithiasis
- How many people
- 3,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2024to 30 Oct 2025
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is descibed under in/exclusion criteria
All patients >18 years with a calculous cholecystitis as primary reason for their hospital admittance. Location of diagnosis may the emergency department, the ward during admittance for diagnostics, or during diagnostic laparoscopy. Cholecystitis is defined according to the TG18 diagnostic criteria for a definitive diagnosis of cholecystitis: A. Local signs of inflammation (Murphy's sign and or RUQ mass/pain/tenderness) + B. Systemic signs of inflammation (Fever, elevated CRP and/or elevated WBC count) + C. Imaging findings characteristic of acute cholecystitis. Patients with a suspected diagnosis (one item in A + one item in B + C), of which the diagnosis is confirmed by peroperative findings, are also included. Patients will be identified by a local study investigator, e.g. a surgeon or surgeon in training.
Trial locations and contacts
1 site in 1 country.
Max van Maasakkers contact
Netherlands1 site, 1 recruiting
- Recruiting
Heelkunde
Nieuwegein, Utrecht, 3435CM
D Boerma, Dr.
About this study
Official title: Variation in Cholecystitis Treatment and Outcome in the Netherlands; a Nation-wide Cohort Study
Background: Cholecystitis is treated by in various types of hospitals by different specialists, and treatment strategy is influenced by logistical and medical reasons and personal preference. This may significantly impact hospital stay and other outcomes.
Purpose: To determine the variation in treatment of cholecystitis in the Netherlands and its impact on outcome.
Read more
Methods: Nation-wide cohort study of all patients diagnosed and treated for cholecystitis during a 6 month period. The primary outcome will be the proportion of patients with an acute cholecystitis in which the guideline is followed. This group will be compared to those in which the guideline is not followed, focussing on total hospital stay and complications. Secondary aims are to determine: factors related to guideline compliance; the best method of cystic duct closure; the best treatment strategy for a >7-day existing cholecystitis; factors predictive for concomitant common bile duct stones; strategies following gallbladder drainage. Multivariable analysis and propensity score matching will be used when appropriate for the etiological study aims. The TRIPOD guideline for prediction modelling will be used for the predictive study aims. Hospitals will receive their own results, set out against the national average and best practices, thereafter subsequent changes in hospital practice will be recorded.
Conclusion: This study will determine the variation in treatment of cholecystitis in the Netherlands and its impact on clinical outcome. Its results will serve as an important incentive to create optimal, uniform cholecystitis treatment in the Netherlands.
- Medical subject headings
- Cholecystitis, Gallstones, Choledocholithiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Total hospital stay
Median (IQR) or mean (+/-SD) hospital stay in days for patients diagnosed with calculous cholecystitis for the cholecystitis or new complications related to their gallstones following the initial cholecystitis episode, this also includes admission for complications of treatments received. This is the primary outcome for the primary comparison: patients with a 0-7 day cholecystitis receiving early cholecystectomy conform the guidelines versus patients with a 0-7 day cholecystitis who receive alternative treatments.
Measured: First six months following diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Apr 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholecystitisStudies 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)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Antonius Onderzoeksfonds, Dutch Snapshot Research Group, Nederlandse Leverpatientenvereniging
- Responsible party
- Principal investigator, Teus Weijs, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349863
- Sponsor's protocol ID
- W23.225
- Acronym
- Dutch CHESS
- Status last verified
- Aug 2024
- First submitted
- 31 Mar 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Maasakkers MHG, Weijs TJ, Goense L, van Lienden KP, van Duijvendijk P, Verdonk RC, Boerma D. Uncovering variation in cholecystitis treatment: protocol and statistical analysis plan for a nationwide observational study - the Dutch Cholecystitis Snapshot Study (Dutch CHESS). BMJ Open. 2025 May 13;15(5):e093821. doi: 10.1136/bmjopen-2024-093821.
PubMed 40360397
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variation in Cholecystitis Treatment and Outcome in the Netherlands; a Nation-wide Cohort Study
- ClinicalTrials.gov ID
- NCT06349863
- Acronym / sponsor ID
- Dutch CHESS / W23.225
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Collaborators
- St. Antonius Onderzoeksfonds, Dutch Snapshot Research Group, Nederlandse Leverpatientenvereniging
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 5 Apr 2024 (actual)
- 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.
Background: Cholecystitis is treated by in various types of hospitals by different specialists, and treatment strategy is influenced by logistical and medical reasons and personal preference. This may significantly impact hospital stay and other outcomes.
Purpose: To determine the variation in treatment of cholecystitis in the Netherlands and its impact on outcome.
Methods: Nation-wide cohort study of all patients diagnosed and treated for cholecystitis during a 6 month period. The primary outcome will be the proportion of patients with an acute cholecystitis in which the guideline is followed. This group will be compared to those in which the guideline is not followed, focussing on total hospital stay and complications. Secondary aims are to determine: factors related to guideline compliance; the best method of cystic duct closure; the best treatment strategy for a >7-day existing cholecystitis; factors predictive for concomitant common bile duct stones; strategies following gallbladder drainage. Multivariable analysis and propensity score matching will be used when appropriate for the etiological study aims. The TRIPOD guideline for prediction modelling will be used for the predictive study aims. Hospitals will receive their own results, set out against the national average and best practices, thereafter subsequent changes in hospital practice will be recorded.
Conclusion: This study will determine the variation in treatment of cholecystitis in the Netherlands and its impact on clinical outcome. Its results will serve as an important incentive to create optimal, uniform cholecystitis treatment in the Netherlands.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is descibed under in/exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total hospital stay
Time frame: First six months following diagnosis
Median (IQR) or mean (+/-SD) hospital stay in days for patients diagnosed with calculous cholecystitis for the cholecystitis or new complications related to their gallstones following the initial cholecystitis episode, this also includes admission for complications of treatments received. This is the primary outcome for the primary comparison: patients with a 0-7 day cholecystitis receiving early cholecystectomy conform the guidelines versus patients with a 0-7 day cholecystitis who receive alternative treatments.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Derived from this study: PubMed 40360397van Maasakkers MHG, Weijs TJ, Goense L, van Lienden KP, van Duijvendijk P, Verdonk RC, Boerma D. Uncovering variation in cholecystitis treatment: protocol and statistical analysis plan for a nationwide observational study - the Dutch Cholecystitis Snapshot Study (Dutch CHESS). BMJ Open. 2025 May 13;15(5):e093821. doi: 10.1136/bmjopen-2024-093821.
- 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.
Max van Maasakkers contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystitis and Cholecystitis; Gallstone, run by St. Antonius Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Teus Weijs (0031612093752, t.j.weijs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total hospital stay (time frame: First six months following diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06349863, which also lists 1 linked publication.
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 12 Aug 2024.