Clinical trial NCT02972944: Laparoscopic Cholecystectomy or Conservative Treatment in the Acute Cholecystitis of Elderly Patients
Official title: Acute Cholecystitis in the Elderly: Comparative Randomized and Cohort Study of Laparoscopic Cholecystectomy vs. Conservative Treatment With Antibiotics Alone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholecystitis, Acute
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Turku University Hospital
name: Tampere University Hospital
name: Oulu University Hospital
name: Mikkeli Central Hospital
name: North Karelia Central Hospital
name: Jyväskylä Central Hospital
name: Päijänne Tavastia Central Hospital
name: Central Hospital of Hämeenlinna
name: Central Hospital of Jorvi
First posted: 2016-11-25
Enrollment: 200
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Specific Morbidity Index Scores
timeFrame: 1 year postoperatively
Secondary outcomes:
measure: Quality of life RAND-36 scores
timeFrame: pre-operatively and 1 year postoperatively
measure: Pain scores (0-100)
timeFrame: pre-operatively, 1 week, 1 month and 1 year postoperatively
measure: Number of patients with failure of antibiotic therapy
timeFrame: 1 week, 1 month and 1 year postoperatively
measure: Time of hospitalization (days)
timeFrame: 1 month
measure: Mortality (number of patients)
timeFrame: 1 month
measure: Number of patients with complications
timeFrame: 1 week, 1 month and 1 year postoperatively
measure: Cost analysis in euros
timeFrame: 1 week, 1 month and 1 year postoperatively
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Pohjois-Savo
Study officials:
References: