CholecystolithiasisNCT07022665
Influence of Hospital Volume on Mortality and Short-term Postoperative Outcomes in Uncomplex General Surgery in Switzerland
An observational study of Cholecystolithiasis and Cholecystitis, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
The effect of centralisation measures on the operative outcomes after any type of surgery in Switzerland has not been highlighted yet. This study aims to investigate the influence of the annual case-specific hospital volume on uncomplex general surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cholecystolithiasis, Cholecystitis, Inguinal Hernia
- What is being tested?
- Appendicectomy, Cholecystectomy and Umbilical hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 399,701 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2013to 1 Mar 2023
- How long will I take part?
- 90 Days
- 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 20 years and older
- All sexes
- Adult, Older adult
Study population: All patients with with appendicectomy for appendicitis, cholecystectomy for cholecystolithiasis and/or cholecystitis , umbilical hernia repair, or inguinal and/or femoral hernia repair operated in Switzerland between 2013 and 2022.
Who may be able to join
- All patients with appendicectomy for appendicitis, cholecystectomy for cholecystolithiasis and/or cholecystitis , umbilical hernia repair, or inguinal and/or femoral hernia repair
Who cannot join
- incomplete case documentation
- age under 20 years
- other hospitals than general or surgical hospitals
- no index operation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
HOCH Health Ostschweiz, Kantonsspital St.Gallen
Sankt Gallen, St.Gallen, 9000
About this study
Official title: Influence of Hospital Volume on Mortality and Short-term Postoperative Outcomes in Uncomplex General Surgery in Switzerland: A Retrospective National Registry Study
The effect of centralisation measures on the operative outcomes after any type of surgery in Switzerland has not been highlighted yet. This study aims to investigate the influence of the annual case-specific hospital volume on uncomplex general surgery. The four operations investigated are appendectomy, cholecystectomy, umbilical hernia repair, and inguinal/femoral hernia repair.
- Conditions
- Cholecystolithiasis, Cholecystitis, Inguinal Hernia, Femoral Hernia, Umbilical Hernia, Appendicitis
- Being tested
- Appendicectomy, Cholecystectomy, Umbilical hernia repair, Inguinal and/or femoral hernia repair
- Medical subject headings
- Cholecystolithiasis, Cholecystitis, Hernia, Inguinal, Hernia, Femoral, Hernia, Umbilical, Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppendicectomyProcedure or surgery
Appendicectomy for appendicitis
CholecystectomyProcedure or surgery
Cholecystectomy for cholecystolithiasis and/or cholecystitis
Umbilical hernia repairProcedure or surgery
Any kind of umbilical hernia repair
Inguinal and/or femoral hernia repairProcedure or surgery
Any kind of inguinal and/or femoral hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Appendicectomy | Not described Receives: Procedure: Appendicectomy | |
| Cholecystectomy | Not described Receives: Procedure: Cholecystectomy | |
| Umbilical hernia repair | Not described Receives: Procedure: Umbilical hernia repair | |
| Inguinal and/or femoral hernia repair | Not described Receives: Procedure: Inguinal and/or femoral hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
The association between the hospital volume and the postoperative mortality Mortality Yes or No Hospital volume as marginal effect Association with GAM logistic regression
Measured: Periprocedural
Secondary outcomes (3)
Reoperation
The association between the hospital volume and the reoperation rate Reoperation Yes or No Hospital volume as marginal effect Association with GAM logistic regression
Measured: Periprocedural
Length of hospital stay
The association between the hospital volume and the length of hospital stay Length of hospital stay in days Hospital volume as marginal effect Association with quantile regression
Measured: Periprocedural
Sociodemographic trends
Measured: 2013 - 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start1 Jan 2013
- Primary completion31 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystolithiasisStudies 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
- 399,701 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanic Ammann, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022665
- Sponsor's protocol ID
- hospital volume surgery
- Status last verified
- Jun 2025
- First submitted
- 26 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Hospital Volume on Mortality and Short-term Postoperative Outcomes in Uncomplex General Surgery in Switzerland: A Retrospective National Registry Study
- ClinicalTrials.gov ID
- NCT07022665
- Acronym / sponsor ID
- hospital volume surgery
- Conditions
- Cholecystolithiasis, Cholecystitis, Inguinal Hernia, Femoral Hernia, Umbilical Hernia, Appendicitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 399,701 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 15 Jun 2025 (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.
The effect of centralisation measures on the operative outcomes after any type of surgery in Switzerland has not been highlighted yet. This study aims to investigate the influence of the annual case-specific hospital volume on uncomplex general surgery. The four operations investigated are appendectomy, cholecystectomy, umbilical hernia repair, and inguinal/femoral hernia repair.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Appendicectomy | – | Procedure: Appendicectomy |
| Cholecystectomy | – | Procedure: Cholecystectomy |
| Umbilical hernia repair | – | Procedure: Umbilical hernia repair |
| Inguinal and/or femoral hernia repair | – | Procedure: Inguinal and/or femoral hernia repair |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with with appendicectomy for appendicitis, cholecystectomy for cholecystolithiasis and/or cholecystitis , umbilical hernia repair, or inguinal and/or femoral hernia repair operated in Switzerland between 2013 and 2022.
Key inclusion criteria (1 listed)
- All patients with appendicectomy for appendicitis, cholecystectomy for cholecystolithiasis and/or cholecystitis , umbilical hernia repair, or inguinal and/or femoral hernia repair
Key exclusion criteria (4 listed)
- incomplete case documentation
- age under 20 years
- other hospitals than general or surgical hospitals
- no index operation
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 |
|---|---|---|
| AppendicectomyAppendicectomy for appendicitis | Procedure or surgery | Appendicectomy |
| CholecystectomyCholecystectomy for cholecystolithiasis and/or cholecystitis | Procedure or surgery | Cholecystectomy |
| Umbilical hernia repairAny kind of umbilical hernia repair | Procedure or surgery | Umbilical hernia repair |
| Inguinal and/or femoral hernia repairAny kind of inguinal and/or femoral hernia repair | Procedure or surgery | Inguinal and/or femoral hernia repair |
Primary outcome
Mortality
Time frame: Periprocedural
The association between the hospital volume and the postoperative mortality Mortality Yes or No Hospital volume as marginal effect Association with GAM logistic regression
3 secondary outcomes
Reoperation
Time frame: Periprocedural
Length of hospital stay
Time frame: Periprocedural
Sociodemographic trends
Time frame: 2013 - 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- 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.
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 Cholecystolithiasis and Cholecystitis, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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: finished, as of the sponsor's last update on 15 Jun 2025. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality (time frame: Periprocedural). 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 15 Jun 2025.