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Acute CholecystitisNCT06559449

Cholecystectomy During Weekends

An observational study of Acute Cholecystitis, run by Umeå University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Acute cholecystitis is the most common acute complication of gallstone disease. Although there are diverging opinions about optimal timing for surgery, the general recommendation is that surgery is performed as soon as possible after admission when the diagnosis is established. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Cholecystitis
How many people
15,730 participants
Where
1 siteSweden
Study dates
1 Aug 2022to 1 Aug 2024
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
  • Adult, Older adult

Study population: Patients undergoing cholecystectomy with ongoing acute cholecystitis that are registered in GallRiks (the Swedish Gallstone Surgery and ERCP register)

Who may be able to join

  • Patients with the diagnosis of ongoing acute cholecystitis.
  • Undergoing surgery on a weekend or national holiday.
  • Staying in hospital during weekend and undergoing surgery on any subsequent weekday.

Who cannot join

  • Paediatric patients (<18 years)
  • Patients who underwent surgery more than 7 days after admission
  • Patients admitted and operated on during weekdays during the same week
  • Patients with missing data regarding age, sex, American Society of Anesthesiologists Classification system (ASA grade), surgical approach, operating time, or complications.

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • University Hospital of Umeå

    Umeå, 90737

Other trials in Sweden

About this study

Official title: Cholecystectomy for Acute Cholecystitis During Weekend Compared to Delayed Weekday Surgery- a Nationwide Population Cohort Study

Acute cholecystitis is the most common acute complication of gallstone disease. Although there are diverging opinions about optimal timing for surgery, the general recommendation is that surgery is performed as soon as possible after admission when the diagnosis is established. The study will compare acute cholecystectomies for acute cholecystitis performed during weekends with procedures where patient have been waiting during weekend and surgery performed during a subsequent weekday.

Hypothesis: Performing acute cholecystectomies for acute cholecystitis during weekends are associated with higher risk for complications.

Read the detailed description

Acute cholecystitis is the most common acute complication of gallstone disease. About 15-20% of all cholecystectomies is performed because of acute cholecystitis. Laparoscopic cholecystectomy is one of the most common acute surgical procedure, and several studies have tried to identify the optimal time between debut of symptoms and surgery.

Although there are diverging opinions about optimal timing for surgery, the general recommendation is that surgery is performed as soon as possible after admission when the diagnosis is established. According to the latest Tokyo Guidelines, early laparoscopic cholecystectomy is the recommended treatment for all severity grades of acute cholecystitis, and delayed surgery is only recommended for selected high-risk patients. An English study based on data from a national register have shown that surgery within three days after admission is recommended for patients with acute cholecystitis. A randomised controlled trail (RCT) with the same formulation of question would need a large number of patients to reach sufficient power, which makes it impossible to perform a study of that kind during a reasonable time. An alternative to RCT studies is studies based on national register data which provides a large number of patients to achieve sufficient statistical power.

In daily clinical practice, there are often other acute surgical procedures with higher priority, leading to down prioritizing of acute cholecystectomies causing the surgery to be delayed. This is common despite that early cholecystectomy generally is accepted as golden standard for acute cholecystitis. Although there are sufficient evidence that risk for complication, days admitted at hospital and risk for conversion to open surgery are increased for every day that surgery is postponed, the phenomenon of delay is usual. To avoid delay of surgery, many clinics perform cholecystectomies during weekends and out-of-hours. Results from studies that compare complication rate between cholecystectomies performed during out-of-hours and office-hours are contradictive. This difference seems to be even larger for cholecystectomies that are performed during weekends, when there are often surgeons during internship and surgeons not specialized in upper GI-surgery on call. To this day, there are no published studies that investigates acute cholecystectomies following acute cholecystitis performed during weekend compared to operations that are delayed until the next following weekday.

The study will be a population-based cohort studie. Data will be extracted from the Swedish gallstone surgery and Retrograde Cholangiopancreatography register (GallRiks). The register is established and have collected data about patients undergoing cholecystectomies and ERCPs since 2005. More than 90% of all cholecystectomies and endoscopic retrograde cholangiopancreaticographies (ERCPs) performed in Sweden are registered. About 20 000 procedures (12 000 cholecystectomies and 8000 ERCPs) are annually registered, and data about indication for surgery, surgical technique, duration of surgery and complications.

Keywords
Cholecystitis, Emergency surgery, Laparoscopic cholecystectomy, Weekend surgery
Medical subject headings
Cholecystitis, Acute, Cholecystitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06559449
Study groupRoleWhat they receive
Weekend surgeryPatients undergoing surgery during weekend or national holiday
Weekday groupPatients waiting in hospital during weekend and undergoing surgery during a weekday

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complication rate

    Number of patients with registered complications after surgery

    Measured: 30 days

Secondary outcomes (2)
  1. Open surgery

    Number of surgical procedures completed with open technique (open or laparoscopic converted to open)

    Measured: 30 days

  2. Prolonged surgery

    Number of surgical procedures with operating time more than 2 hours

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start1 Aug 2022
  3. Primary completion1 Jan 2023
  4. Study completion1 Aug 2024

Resources

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
Retrospective
Enrolment
15,730 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06559449
Sponsor's protocol ID
10105555
Status last verified
Aug 2024
First submitted
14 Aug 2024
Last updated
21 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Cholecystitis, run by Umeå University at 1 site in Sweden.

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 3 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 21 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 Sweden. 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?

Complication rate (time frame: 30 days). 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 21 Aug 2024.

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