Laparoscopic Cholecystectomy or Conservative Treatment in the Acute Cholecystitis of Elderly Patients
- Conditions
- Cholecystitis, Acute
- Interventions
- Procedure: Non-operative treatmentProcedure: Laparoscopic cholecystectomy
- Registration Number
- NCT02972944
- Lead Sponsor
- Kuopio University Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Radiologically confirmed acute cholecystitis
- Age over 75 yrs
- American Association of Anesthesiologists Classification class 2-3
- Duration of symptoms < 5 days
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-operative group Non-operative treatment Patients of non-operative group will be treated conservatively with intravenous antibiotics (cefuroxime) at surgical ward. Elective cholecystectomy will not be arranged. Cholecystectomy group Laparoscopic cholecystectomy Cholecystectomy group will undergo laparoscopic cholecystectomy within 48 hrs after randomization.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Pain scores (0-100) pre-operatively, 1 week, 1 month and 1 year postoperatively Pain (VAS, range 0-100)
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
Mortality (number of patients) 1 month Death within 30 d
Number of patients with failure of antibiotic therapy 1 week, 1 month and 1 year postoperatively Recurrent cholecystitis after antibiotic therapy
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
Trial Locations
- Locations (1)
Kuopio University Hospital
🇫🇮Kuopio, Pohjois-Savo, Finland