Acute CholecystitisNCT04308265
Scoring System in Acute Calculous Cholecystitis
An observational study of Acute Cholecystitis, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cholecystitis
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Mar 2020to 15 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the hospital for acute cholecystitis older than 18 years will constitute the study population.
Who may be able to join
- Clinically and Radiologically diagnosed with acute cholecystitis
- be over 18 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Training and Research Hospital
Konya, 42090
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Cholecystitis
- Medical subject headings
- Cholecystitis, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
cut off value
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.
Measured: Three months
The score will be determined.
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
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start7 Mar 2020
- Primary completion28 Feb 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alpaslan Şahin, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308265
- Sponsor's protocol ID
- Department of general surgery
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2020
- Last updated
- 23 Mar 2021
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Ozkardes AB, Tokac M, Dumlu EG, Bozkurt B, Ciftci AB, Yetisir F, Kilic M. Early versus delayed laparoscopic cholecystectomy for acute cholecystitis: a prospective, randomized study. Int Surg. 2014 Jan-Feb;99(1):56-61. doi: 10.9738/INTSURG-D-13-00068.1.
PubMed 24444271Ambe PC, Papadakis M, Zirngibl H. A proposal for a preoperative clinical scoring system for acute cholecystitis. J Surg Res. 2016 Feb;200(2):473-9. doi: 10.1016/j.jss.2015.09.010. Epub 2015 Sep 9.
PubMed 26443188
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Scoring System Affect the Surgery Timing in Acute Calculous Cholecystitis?
- ClinicalTrials.gov ID
- NCT04308265
- Acronym / sponsor ID
- Department of general surgery
- Conditions
- Acute Cholecystitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 7 Mar 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the hospital for acute cholecystitis older than 18 years will constitute the study population.
Key inclusion criteria (2 listed)
- Clinically and Radiologically diagnosed with acute cholecystitis
- be over 18 years old
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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) * AGE * GENDER * Body Mass Index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Background: PubMed 24444271Ozkardes AB, Tokac M, Dumlu EG, Bozkurt B, Ciftci AB, Yetisir F, Kilic M. Early versus delayed laparoscopic cholecystectomy for acute cholecystitis: a prospective, randomized study. Int Surg. 2014 Jan-Feb;99(1):56-61. doi: 10.9738/INTSURG-D-13-00068.1.
- Results publication: PubMed 26443188Ambe PC, Papadakis M, Zirngibl H. A proposal for a preoperative clinical scoring system for acute cholecystitis. J Surg Res. 2016 Feb;200(2):473-9. doi: 10.1016/j.jss.2015.09.010. Epub 2015 Sep 9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cholecystitis, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cut off value (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04308265, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021; AzTrials last refreshed its copy on 29 Oct 2026.