Brief Title
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
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.
Study Type
Interventional
Primary Outcome
Specific Morbidity Index Scores
Secondary Outcome
Quality of life RAND-36 scores
Condition
Cholecystitis, Acute
Intervention
Laparoscopic cholecystectomy
Study Arms / Comparison Groups
Cholecystectomy group
Description: Cholecystectomy group will undergo laparoscopic cholecystectomy within 48 hrs after randomization.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
200
Start Date
October 2016
Completion Date
December 2021
Primary Completion Date
December 2021
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
Gender
All
Ages
75 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
, 17 173 311, [email protected]
Location Countries
Finland
Location Countries
Finland
Administrative Informations
NCT ID
NCT02972944
Organization ID
326/2016
Responsible Party
Principal Investigator
Study Sponsor
Kuopio University Hospital
Collaborators
Turku University Hospital
Study Sponsor
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Verification Date
February 2021