Scoring System in Acute Calculous Cholecystitis
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|ClinicalTrials.gov Identifier: NCT04308265|
Recruitment Status : Completed
First Posted : March 16, 2020
Last Update Posted : March 23, 2021
|Condition or disease|
Acute cholecystitis refers to acute inflammation of the gallbladder, and why it is often gallstones. Gallstones are seen in western society with about 10% frequency, while 80% of them are asymptomatic. Acute cholecystitis accounts for 1-3% of those with symptomatic gallstones.
Acute cholecystitis is a table characterized by right upper quadrant pain (in the inflammatory pain pattern and continuous), defensiveness in the right upper quadrant (murphy manifestation is positive or not), and an increase in inflammatory response parameters (such as fever, white blood cell, and CRP elevation). Biliary scintigraphy, called the HIDA scan, is the gold standard method in diagnosis. However, due to the difficulty and cost of application, ultrasonography is used in the routine application in diagnosis. It is valuable that gallstones and gallbladder walls are thicker than 4 mm in ultrasonography. However, pericholecystic fluid is a more valuable finding and is rare.
In the treatment of acute cholecystitis, the patient's hospitalization, limiting oral food intake, IV hydration, NSAID, and antibiotic treatment is the main conservative approaches. While these patients were admitted to the hospital in the first 72 hours from the onset of symptoms, early cholecystectomy is recommended. If they arrive later, interval cholecystectomy is recommended after 6-8 weeks. Laparoscopic cholecystectomy is recommended for all operations. However, the choice of surgical treatment is determined by the surgeon, according to the patient. More precise and objective criteria are needed to contribute to this choice.
In a study comparing early cholecystectomy and delayed cholecystectomy, intraoperative and postoperative complications were more common in early cholecystectomy than interval cholecystectomy. Still, early cholecystectomy had better results in terms of cost and hospital stay. There are many studies in the literature comparing early and late cholecystectomy. In these studies, the selection criteria of patients are different in all of them.
Finally, it was emphasized that a retrospective scoring study conducted in Germany could be successful in patient selection.
In conclusion, the debate on treatment choices of patients with acute cholecystitis continues. Recent publications in the literature on the development of scoring systems for these patients draw attention, so investigators want to investigate the effectiveness of a scoring system in which patients are evaluated in many ways.
|Study Type :||Observational|
|Actual Enrollment :||1 participants|
|Official Title:||Does the Scoring System Affect the Surgery Timing in Acute Calculous Cholecystitis?|
|Actual Study Start Date :||March 7, 2020|
|Actual Primary Completion Date :||February 28, 2021|
|Actual Study Completion Date :||March 15, 2021|
- cut off value [ Time Frame: Three months ]
After entering the patients' data entries and scoring points, ROC analysis will be done with the SPSS program. The resulting cut off value is given to us; It will provide information about which patients to recommend early cholecystectomy, which patients should seek medical treatment and other solutions.
Values above the cut-off value to be analyzed will be considered bad value. If values above the cut off value are found, surgery will not be preferred.
- The score will be determined. [ Time Frame: Three months ]
A score will be determined with the scoring system created using the history, history information, hemogram, biochemistry tests, ultrasonography findings of the patients admitted to the study, and the height and bodyweight of the patients.
Scoring will be created using the following information;
- Diabetes Mellitus story
- White Blood Cell
- C Reactive Protein (CRP)
- Wall thickness of gall bladder
- Pericholecystic Fluid
- Acute Cholecystitis Attack Number
- Pain start time (hours)
- Body Mass Index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04308265
|Konya Training and Research Hospital|
|Konya, Turkey, 42090|