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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
Sponsor:
Information provided by (Responsible Party):
Alpaslan Şahin, Konya Training and Research Hospital

Brief Summary:
Acute cholecystitis is a common disease in the daily practice of general surgery. There are various methods in the treatment of this disease, such as early cholecystectomy, medical treatment, six weeks later cholecystectomy and cholecystostomy. However, it is not satisfied with objective criteria that these methods are selected according to which patient groups. With this observational-prospective study, the benefit of first visit scoring on 'which of the treatment options will be most suitable for the patient' will be investigated. Thus, rare but severe complications of cholecystectomy can be prevented.

Condition or disease
Acute Cholecystitis

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


  2. 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)
    • AGE
    • GENDER
    • Body Mass Index



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the hospital for acute cholecystitis older than 18 years will constitute the study population.
Criteria

Inclusion Criteria:

  • Clinically and Radiologically diagnosed with acute cholecystitis
  • be over 18 years old

Exclusion Criteria:

  • Being under the age of 18
  • getting pregnant
  • Acute pancreatitis, cholangitis or choledochal stone with acute cholecystitis
  • Having a previous history of upper abdominal surgery

Information from the National Library of Medicine

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


Locations
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Turkey
Konya Training and Research Hospital
Konya, Turkey, 42090
Sponsors and Collaborators
Konya Training and Research Hospital
Publications of Results:
Other Publications:
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Responsible Party: Alpaslan Şahin, principal investigators, Konya Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04308265    
Other Study ID Numbers: Department of general surgery
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases