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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 (ABCâ„¢). 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute laparoscopic cholecystectomy | Patients with gallbladder inflammation. 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Benchmark values of acute 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 acute laparoscopic cholecystectomy | The study will use the ABC methodology to identify reference values of 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 acute 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 gallbladder inflammation.
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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 |