Chronic Cholecystitis
Conditions
Brief summary
Post-marketing Observational Clinical Study: Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice
Interventions
None listed
Sponsors
Kazakhstan Scientific Society for Study of intestine diseases
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Inclusion criteria
* Men and women aged 18 to 65 years; * BMI 18.5 - 40; * Verified diagnosis: chronic acalculous cholecystitis; * Voluntary desire to provide informed consent to participate in the study
Exclusion criteria
* Presence of stones in the gall bladder and bile ducts; * The presence of jaundice, cholestatic liver diseases, liver cirrhosis with decompensation; * Increased ALT, AST above the 3 upper limits of normal; * Hypersensitivity to the components of the drug Odeston; * Pregnancy and lactation; * Prolonged fasting and total parenteral nutrition; * Patients with symptoms of acute abdomen at the time of inclusion in the study; * Patients with symptoms of acute neurological pathology at the time of inclusion in the study and/or аcute cerebrovascular accident, a history of convulsive syndrome; * Presence of cancer; * Acute infectious diseases at the time of inclusion in the study; * Fever of any origin (above 37.5 C); * Patients with symptoms of heart failure; * Patients with symptoms of pulmonary failure; * Patients with symptoms of acute or chronic renal failure; * A decompensated form of diabetes; * Patients with signs of psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dynamics of Visual Analogue Scale scores for the severity and frequency of pain symptoms | on day 21 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with a decrease in the severity of dyspeptic syndrome based on the Leeds Questionnaire | on day 21 |
| Dynamics of quality of life indicators based on the Digestive Quality of Life Questionnaire | on day 21 |
| Incidence of SUSAR | on day 21 |
| The dynamics of Aspartate aminotransferase | on day 21 |
| The dynamics of Alanine aminotransferase | on day 21 |
| The dynamics of Alkaline phosphatase | on day 21 |
| The dynamics of Gamma-glutamyl transpeptidase | on day 21 |
| The dynamics of bilirubin with fractions | on day 21 |
| Types of concomitant therapy uses | on day 21 |
| Frequency of use of concomitant therapy | on day 21 |
| Assessment of the shape of the gallbladder by ultrasound | on day 21 |
| Assessment of the size of the gallbladder by ultrasound | on day 21 |
| Assessment of the thickness of the gallbladder walls by ultrasound | on day 21 |
| Assessment of the presence of intraluminal formations of the bladder by ultrasound | on day 21 |
| Assessment of the presence of an acoustic shadow by ultrasound | on day 21 |
| Assessment of the mobility of intraluminal formations by ultrasound | on day 21 |
| Assessment of the presence of biliary sludge by ultrasound | on day 21 |
| Assessment of the size of the common bile duct by ultrasound | on day 21 |
| Assessment of the presence of dilatation of the intrahepatic bile ducts by ultrasound | on day 21 |
| Assessment of the presence of additional formations using ultrasound | on day 21 |
Countries
Kazakhstan
Contacts
Primary ContactKanat Khazhidinov
Backup ContactYekaterina Sakhabutdinova
Outcome results
None listed