Laparoscopic Cholecystectomy or Conservative Treatment in the Acute Cholecystitis of Elderly Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acute Cholecystitis in the Elderly: Comparative Randomized and Cohort Study of Laparoscopic Cholecystectomy vs. Conservative Treatment With Antibiotics Alone

Conditions
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Cholecystitis, Acute

Intervention / Treatment
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* Procedure: Laparoscopic cholecystectomy
* Procedure: Non-operative treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cholecystectomy group<br>Cholecystectomy group will undergo laparoscopic cholecystectomy within 48 hrs after randomization. | Procedure: Laparoscopic cholecystectomy<br> <br> |
| Active Comparator: Non-operative group<br>Patients of non-operative group will be treated conservatively with intravenous antibiotics (cefuroxime) at surgical ward. Elective cholecystectomy will not be arranged. | Procedure: Non-operative treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific Morbidity Index Scores | 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) | 1 year postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life RAND-36 scores | Quality of life according to RAND-36 | pre-operatively and 1 year postoperatively | 
| Pain scores (0-100) | Pain (VAS, range 0-100) | pre-operatively, 1 week, 1 month and 1 year postoperatively | 
| Number of patients with failure of antibiotic therapy | Recurrent cholecystitis after antibiotic therapy | 1 week, 1 month and 1 year postoperatively | 
| Time of hospitalization (days) | Length of time at hospital | 1 month | 
| Mortality (number of patients) | Death within 30 d | 1 month | 
| Number of patients with complications | Bile duct injury, re-operations, bile leakage, hemorragia, wound infections, pneumonia etc. | 1 week, 1 month and 1 year postoperatively | 
| Cost analysis in euros | cost analysis comparison between groups | 1 week, 1 month and 1 year postoperatively |