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Benchmarks in Acute Laparoscopic Cholecystectomy

NCT ID: NCT06693076

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2023-12-31

Brief Summary

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The aim of this observational cohort study is to define peri- and postoperative reference values for acute laparoscopic cholecystectomy, using the achievable benchmarks of care methodology (ABC™). Another aim is to develop adjusted reference values for groups with a risk factor of severe postoperative complications. The goal is to spur quality improvement initiatives.

Detailed Description

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The data source is the Swedish patient registry GallRiks, a prospective quality registry for gallbladder surgery and endoscopic retrograde cholangio-pancreatography (ERCP). The time frame will be 2015-2023. Register variables related to surgical quality will be analyzed, such as postoperative complications, perioperative adverse events, surgical duration and length of stay. The study will analyze data for the time of surgery and up to 30 days afterwards. As the researchers do not yet have the data available, the exact number of enrolled participants can not yet be given.

Conditions

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Gallbladder Gall Stones (&Amp; [Calculus - Gall Bladder]) Gall Stone Gallbladder Inflammation

Keywords

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laparoscopic cholecystectomy benchmarking surgical outcomes reference values quality improvement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Acute laparoscopic cholecystectomy

Patients with gallbladder inflammation. ERCP may be involved if a gallstone is detected in the common bile duct perioperatively.

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

The intervention in this study is urgent, not elective. The conditions for the surgery are therefore different: any time of day, the surgeon on shift, the state of the patients.

Interventions

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Laparoscopic cholecystectomy

The intervention in this study is urgent, not elective. The conditions for the surgery are therefore different: any time of day, the surgeon on shift, the state of the patients.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* adults ≥ 18 years of age
* laparoscopic acute cholecystectomy

Exclusion Criteria

* other indications than acute cholecystitis will be excluded
* cholecystectomy due to malignancy
* other organ surgery performed at the same occasion
* previous upper gastrointestinal surgery
* single port access
* robotic surgery
* no data concerning surgical intervention
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Östergötland

OTHER

Sponsor Role lead

Responsible Party

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Ebba Kihlstedt Pasquier

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2024-06020-02

Identifier Type: -

Identifier Source: org_study_id