NCT04308265

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

12 months

First QC Date

March 10, 2020

Last Update Submit

March 19, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    Three months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Training and Research Hospital

Konya, 42090, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 24444271BACKGROUND
  • Ambe 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.

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

CholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigators

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 16, 2020

Study Start

March 7, 2020

Primary Completion

February 28, 2021

Study Completion

March 15, 2021

Last Updated

March 23, 2021

Record last verified: 2021-03

Locations