Scoring System in Acute Calculous Cholecystitis

March 19, 2021 updated by: Alpaslan Şahin, Konya Meram State Hospital

Does the Scoring System Affect the Surgery Timing in Acute Calculous Cholecystitis?

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey, 42090
        • Konya Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the hospital for acute cholecystitis older than 18 years will constitute the study population.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Three months
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
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya Meram State Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2020

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

March 15, 2021

Study Registration Dates

First Submitted

March 10, 2020

First Submitted That Met QC Criteria

March 11, 2020

First Posted (Actual)

March 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Department of general surgery

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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