Laparoscopic Cholecystectomy or Conservative Treatment in the Acute Cholecystitis of Elderly Patients
NCT ID: NCT02972944
Last Updated: 2021-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2016-10-31
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cholecystectomy group
Cholecystectomy group will undergo laparoscopic cholecystectomy within 48 hrs after randomization.
Laparoscopic cholecystectomy
Non-operative group
Patients of non-operative group will be treated conservatively with intravenous antibiotics (cefuroxime) at surgical ward. Elective cholecystectomy will not be arranged.
Non-operative treatment
Interventions
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Laparoscopic cholecystectomy
Non-operative treatment
Eligibility Criteria
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Inclusion Criteria
* Age over 75 yrs
* American Association of Anesthesiologists Classification class 2-3
* Duration of symptoms \< 5 days
Exclusion Criteria
* 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
75 Years
ALL
Yes
Sponsors
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Turku University Hospital
OTHER_GOV
Tampere University Hospital
OTHER
Oulu University Hospital
OTHER
Mikkeli Central Hospital
OTHER
North Karelia Central Hospital
OTHER
Jyväskylä Central Hospital
OTHER
Päijänne Tavastia Central Hospital
OTHER
Central Hospital of Hämeenlinna
UNKNOWN
Central Hospital of Jorvi
UNKNOWN
Kuopio University Hospital
OTHER
Responsible Party
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Hannu Paajanen
Professor
Locations
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Kuopio University Hospital
Kuopio, Northern Savonia, Finland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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326/2016
Identifier Type: -
Identifier Source: org_study_id