Cholecystitis, Acute
Conditions
Brief summary
Cholecystectomy is the only curative treatment for gallstone disease of acute calculous cholecystitis.The purpose of this study is to find the most effective treatment (laparoscopic cholecystectomy vs. conservative) for elderly patients with acute cholecystitis. Therefore a randomized multi-centre study of 200 elderly patients suffering from acute cholecystitis is performed with additional cohort of all elderly patients with acute cholecystitis in the study hospitals during study period.
Detailed description
The increasing age is one of the main risk factors for developing complicated gallstone disease. Currently, there is lack of good quality studies comparing risks and benefits of early laparoscopic cholecystectomy in the elderly patients. Cholecystectomy is the only curative treatment for gallstone disease of acute calculous cholecystitis. Aim: The purpose is to find out the most effective treatment (laparoscopic cholecystectomy vs. conservative) with the least morbidity for elderly patients with acute cholecystitis. Study design: multicenter randomized controlled trial (RCT) and additional cohort of all elderly patients (\>75 years old) with acute cholecystitis. Patient allocation: Elderly patients with diagnosis of acute cholecystitis will be randomly allocated to either early laparoscopic cholecystectomy or treatment with antibiotics. Reasonably healthy elderly patients (ASA 2-3) are included in this study, excluding the patients with ASA-class above 4. Interventions: The study group of patients will undergo early laparoscopic cholecystectomy within 48 hours after hospitalization. The control group will be managed conservatively with intravenous antibiotics and elective cholecystectomy will not be scheduled later. Primary outcome: Assessment of morbidities related to acute cholecystitis and individual quality of life. Secondary outcomes include number of hospital admissions, length of hospitalization, pain, complications, mortality and cost analysis. Sample size and data-analysis: Based on data of previous studies the recruitment of 200 patients in total is expected. Follow-up will be for 12 months. In addition of RCT, we decided to record and analyze all acute cholecystitis of elderly patients in study hospitals during the study period. We will present these results in the connection of RCT analysis.
Interventions
PROCEDURELaparoscopic cholecystectomy
PROCEDURENon-operative treatment
Sponsors
Turku University Hospital
Tampere University Hospital
Oulu University Hospital
Mikkeli Central Hospital
North Karelia Central Hospital
Jyväskylä Central Hospital
Päijänne Tavastia Central Hospital
Central Hospital of Hämeenlinna
Central Hospital of Jorvi
Kuopio University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Radiologically confirmed acute cholecystitis * Age over 75 yrs * American Association of Anesthesiologists Classification class 2-3 * Duration of symptoms \< 5 days
Exclusion criteria
* American Association of Anesthesiologists Classification class 4-5 * Age under 75 yrs * Peritonitis * Sepsis or septic shock * Duration of symptoms over 6 days * Cholestasis or diagnosed stone at common biliary duct. * Acute Pancreatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specific Morbidity Index Scores | 1 year postoperatively | The primary outcome is morbidity, all complications will be scored (according to morbidity-index -chart) (ref: Gutt et al: Ann Surg 2013;258:385-393) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores (0-100) | pre-operatively, 1 week, 1 month and 1 year postoperatively | Pain (VAS, range 0-100) |
| Number of patients with failure of antibiotic therapy | 1 week, 1 month and 1 year postoperatively | Recurrent cholecystitis after antibiotic therapy |
| Time of hospitalization (days) | 1 month | Length of time at hospital |
| Quality of life RAND-36 scores | pre-operatively and 1 year postoperatively | Quality of life according to RAND-36 |
| Number of patients with complications | 1 week, 1 month and 1 year postoperatively | Bile duct injury, re-operations, bile leakage, hemorragia, wound infections, pneumonia etc. |
| Cost analysis in euros | 1 week, 1 month and 1 year postoperatively | cost analysis comparison between groups |
| Mortality (number of patients) | 1 month | Death within 30 d |
Countries
Finland
Contacts
Primary ContactHannu Paajanen, Professor
Backup ContactAntti Kivivuori, MD
Outcome results
None listed