An observational study in Cholecystitis, Acute, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-26.
Sponsored by Karolinska Institutet · Observational
The aim of this study is:
Patients will be prospectively enrolled. The ultrasound picture (ultrasound variables: gallbladder volume, gallbladder wall thickness, and presence of oedema in the gallbladder wall), will be compared to clinical variables (tenderness in right upper quadrant, WBC, CRP and temperature) and to the time (hours) from onset of symptoms. Statistical analyses will be made to see if statistically significant, and clinically relevant, associations between variables exist.
Furthermore, for participants receiving acute surgery, an upper GI surgeon will evaluate the operation as easy, intermediate or difficult. In extension, investigators will look at associations between difficult surgery and all the variables previously mentioned (both ultrasound variables, clinical variables and time).
Patients admitted to Stockholm South General Hospital's Surgery Department, with a confirmed diagnosis of acute cholecystitis (according to the Tokyo Guidelines 2013) will be considered eligible for the study and asked to participate. Informed consent will be obtained from all participants. Participants will be examined with ultrasound of the gallbladder daily, while receiving regular care for acute cholecystitis, which means either waiting for acute surgery or being treated conservatively for as long as inpatient care is needed.
The ultrasound examinations will be performed by a radiologist or a specialised certified ultrasound trained nurse as well as by an ultrasound trained surgeon. Measures of gallbladder volume (measured in cm3), gallbladder wall thickness (measured in mm:s) and presence of oedema in the gallbladder wall (noted as a binomial variable 'yes/no') are recorded in a case report form (no.1) together with body temperature, labs and information about onset of symptoms.
The operating surgeon (a specialist in surgery) will evaluate the operation and grade it from easy to difficult and fill in a case report form (no.2).
Data will be collected from the forms and analysed using a regression model (generalised estimated equation or a mixed model).
140 studies on the registry are indexed under Cholecystitis, Acute; 30 are open to participants now.
This study's enrollment of 120 is below the median of 216 across 52 observational studies indexed under Cholecystitis, Acute.
Browse Cholecystitis, Acute studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients admitted to the hospital, with confirmed acute cholecystitis according to the Tokyo Guidelines 2013 will be asked to participate in the study
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All included patients will be examined with ultrasound
Does the gallbladder wall thickness in acute cholecystitis change over time?
Measurement of the gallbladder wall thickness in mm will be measured daily. Association between the gallbladder wall thickness and time from onset of symptoms (hours) will be analyzed.
Time frame: Through study completion, one year
Does the gallbladder volume in acute cholecystitis change over time?
Measurement of the gallbladder volume, in cm3 will be measured daily. Association between the gallbladder volume and time from onset of symptoms (hours) will be analyzed.
Time frame: Through study completion, one year
Does the presence of oedema in the gallbladder wall change over time?
The presence of oedema in the gallbladder wall will be examined and noted daily.
Time frame: Through study completion, one year
Does any of the ultrasound variables contribute to predict difficult surgery in acute cholecystitis?
Patients with acute cholecystitis who undergo surgery at the same admission will be included for further analysis. The operating surgeon (a specialist in general surgery) will classify the operation as easy, intermediate or difficult. Associations between difficult surgery, all the above listed variables and time from onset of symptoms will be calculated using a regression model (GEE or mixed model).
Time frame: Through study completion, one year
Ran from Oct 2017 to primary completion in Nov 2018, 13 months.
Of 22 observational studies under Cholecystitis, Acute, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 42. This study's 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.