Acute CholecystitisNCT06559449
Cholecystectomy During Weekends
An observational study of Acute Cholecystitis, run by Umeå University at 1 site in Sweden.
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.
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.
- Conditions
- Acute Cholecystitis
- 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 group | Role | What they receive |
|---|---|---|
| Weekend surgery | Patients undergoing surgery during weekend or national holiday | |
| Weekday group | Patients 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.
Complication rate
Number of patients with registered complications after surgery
Measured: 30 days
Secondary outcomes (2)
Open surgery
Number of surgical procedures completed with open technique (open or laparoscopic converted to open)
Measured: 30 days
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.
- First posted19 Aug 2024
- Study start1 Aug 2022
- Primary completion1 Jan 2023
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Retrospective
- Enrolment
- 15,730 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholecystectomy for Acute Cholecystitis During Weekend Compared to Delayed Weekday Surgery- a Nationwide Population Cohort Study
- ClinicalTrials.gov ID
- NCT06559449
- Acronym / sponsor ID
- 10105555
- Conditions
- Acute Cholecystitis
- Keywords
- Cholecystitis, Emergency surgery, Laparoscopic cholecystectomy, Weekend surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,730 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 19 Aug 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekend surgery | – | –Patients undergoing surgery during weekend or national holiday |
| Weekday group | – | –Patients waiting in hospital during weekend and undergoing surgery during a weekday |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cholecystectomy with ongoing acute cholecystitis that are registered in GallRiks (the Swedish Gallstone Surgery and ERCP register)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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
Complication rate
Time frame: 30 days
Number of patients with registered complications after surgery
2 secondary outcomes
Open surgery
Time frame: 30 days
Prolonged surgery
Time frame: 30 days
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 21 Aug 2024.
- 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 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.