Laparoscopic Cholecystectomy or Conservative Treatment in the Acute Cholecystitis of Elderly Patients
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|ClinicalTrials.gov Identifier: NCT02972944|
Recruitment Status : Recruiting
First Posted : November 25, 2016
Last Update Posted : August 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cholecystitis, Acute||Procedure: Laparoscopic cholecystectomy Procedure: Non-operative treatment||Not Applicable|
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. Laparoscopic 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).
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 other group will be managed conservatively with intravenous antibiotics and elective cholecystectomy will not be scheduled later.
Primary outcome: Assessment of morbidities 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Multi-center Study of Acute Cholecystitis in the Elderly: Comparison of Laparoscopic Cholecystectomy vs. Conservative Treatment With Antibiotics|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: Cholecystectomy group
Cholecystectomy group will undergo laparoscopic cholecystectomy within 48 hrs after randomization.
Procedure: Laparoscopic cholecystectomy
Active Comparator: 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.
Procedure: Non-operative treatment
- Specific Morbidity Index Scores [ Time Frame: 1 year postoperatively ]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)
- Quality of life RAND-36 scores [ Time Frame: pre-operatively and 1 year postoperatively ]Quality of life according to RAND-36
- Pain scores (0-100) [ Time Frame: pre-operatively, 1 week, 1 month and 1 year postoperatively ]Pain (VAS, range 0-100)
- Number of patients with failure of antibiotic therapy [ Time Frame: 1 week, 1 month and 1 year postoperatively ]Recurrent cholecystitis after antibiotic therapy
- Time of hospitalization (days) [ Time Frame: 1 month ]Length of time at hospital
- Mortality (number of patients) [ Time Frame: 1 month ]Death within 30 d
- Number of patients with complications [ Time Frame: 1 week, 1 month and 1 year postoperatively ]Bile duct injury, re-operations, bile leakage, hemorragia, wound infections, pneumonia etc.
- Cost analysis in euros [ Time Frame: 1 week, 1 month and 1 year postoperatively ]cost analysis comparison between groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972944
|Contact: Hannu Paajanen, Professor||17 173 311 ext +358||Hannu.Paajanen@kuh.fi|
|Contact: Antti Kivivuori, MD||443516698 ext +358||Antti.Kivivuori@esshp.fi|
|Kuopio University Hospital||Recruiting|
|Kuopio, Pohjois-Savo, Finland, 70200|
|Contact: Tuomo Rantanen, Professor 17 173 311 ext +358 Tuomo.Rantanen@kuh.fi|