NCT06559449

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,730

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
Last Updated

August 21, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

August 14, 2024

Last Update Submit

August 19, 2024

Conditions

Acute Cholecystitis

Keywords

CholecystitisEmergency surgeryLaparoscopic cholecystectomyWeekend surgery

Outcome Measures

Primary Outcomes (1)

  • Complication rate

    Number of patients with registered complications after surgery

    30 days

Secondary Outcomes (2)

  • Open surgery

    30 days

  • Prolonged surgery

    30 days

Study Arms (2)

Weekend surgery

Patients undergoing surgery during weekend or national holiday

Weekday group

Patients waiting in hospital during weekend and undergoing surgery during a weekday

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Umeå

Umeå, 90737, Sweden

Location

MeSH Terms

Conditions

Cholecystitis, AcuteCholecystitis

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 19, 2024

Study Start

August 1, 2022

Primary Completion

January 1, 2023

Study Completion

August 1, 2024

Last Updated

August 21, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)