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Benchmarks in Elective Laparoscopic Cholecystectomy

NCT ID: NCT06692517

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

60000 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 elective 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 over-arching aim is to inspire 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. Since the data is not yet available to the researchers the number of enrolled study participants can not be specified with certitude; therefore an anticipated number is given.

Conditions

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Gall Stone Gallbladder Inflammation Gall Bladder Pain Gallstone Gall Stones (& [Calculus - Gall Bladder])

Keywords

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Laparoscopic cholecystectomy Benchmarking Surgical Outcomes Reference values Quality Improvement Risk factors of surgical complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Elective cholecystectomy

Elective cholecystectomy. Patients with recurrent gallstone attacks, previous cholecystitis, previous cholangitis, or previous pancreatitis. ERCP may be involved if a gallstone is detected in the common bile duct perioperatively.

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Laparoscopic cholecystectomy

Interventions

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Laparoscopic cholecystectomy

Laparoscopic cholecystectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* adults ≥ 18 years of age
* laparoscopic primary cholecystectomy

Exclusion Criteria

* patients with current acute cholecystitis, pancreatitis or cholangitis
* 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

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2022-04311-01

Identifier Type: -

Identifier Source: org_study_id