An interventional study of Laparoscopic cholecystectomy and Non-operative treatment in Cholecystitis, Acute, sponsored by Kuopio University Hospital. Status unknown at 1 site in Finland. Open to participants aged 75 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-20.
Sponsored by Kuopio University Hospital · Not applicable, Interventional, and Treatment
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.
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.
266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.
This study's planned enrollment of 200 is above the median of 86 across 167 interventional studies indexed under Cholecystitis.
Browse Cholecystitis studies →Kuopio University Hospital is the lead sponsor of 132 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cholecystectomy group will undergo laparoscopic cholecystectomy within 48 hrs after randomization.
Procedure: Laparoscopic cholecystectomy
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
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)
Time frame: 1 year postoperatively
Quality of life RAND-36 scores
Quality of life according to RAND-36
Time frame: pre-operatively and 1 year postoperatively
Pain scores (0-100)
Pain (VAS, range 0-100)
Time frame: pre-operatively, 1 week, 1 month and 1 year postoperatively
Number of patients with failure of antibiotic therapy
Recurrent cholecystitis after antibiotic therapy
Time frame: 1 week, 1 month and 1 year postoperatively
Time of hospitalization (days)
Length of time at hospital
Time frame: 1 month
Mortality (number of patients)
Death within 30 d
Time frame: 1 month
Number of patients with complications
Bile duct injury, re-operations, bile leakage, hemorragia, wound infections, pneumonia etc.
Time frame: 1 week, 1 month and 1 year postoperatively
Cost analysis in euros
cost analysis comparison between groups
Time frame: 1 week, 1 month and 1 year postoperatively
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kuopio University Hospital