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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 (ABCâ„¢). 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic cholecystectomy | Procedure | Laparoscopic cholecystectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Benchmark values of elective laparoscopic cholecystectomy | The study will use the ABC methodology to identify reference values of surgical duration (minutes), perioperative cholangiography, conversion to open surgery and adverse events | Day of surgery |
| Postoperative benchmark values of elective laparoscopic cholecystectomy | The study will use the ABC methodology to identify reference values of the postoperative variables: hospital length of stay (days), abscess/infection, bleeding, biliary leakage, readmission, reoperation | 0-30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted benchmarks for severe complications | Univariable and multivariable logistic regression analysis will be performed to detect any risk factor for severe complications after laparoscopic cholecystectomy. The factors to be investigated are body mass index (kg/m2), age (years), gender, smoking, cardiovascular disease, pulmonary disease, diabetes, immunosuppressive treatment, and treatment with anticoagulants. Adjusted benchmarks will be calculated for factor(s) that in multivariable logistic regression analysis are identified as individual risk factor(s). |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with gall stone disease and, or previous gallbladder inflammation.
Data will be shared upon reasonable request.
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| ID | Term |
|---|---|
| D042882 | Gallstones |
| D002764 | Cholecystitis |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
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| ID | Term |
|---|---|
| D017081 | Cholecystectomy, Laparoscopic |
| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| 0-30 days after surgery |
| D005705 |
| Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |