Laparoscopic Cholecystectomy or Conservative Treatment in the Acute Cholecystitis of Elderly Patients
Primary Purpose
Cholecystitis, Acute
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Laparoscopic cholecystectomy
Non-operative treatment
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystitis, Acute
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
Sites / Locations
- Kuopio University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cholecystectomy group
Non-operative group
Arm Description
Cholecystectomy group will undergo laparoscopic cholecystectomy within 48 hrs after randomization.
Patients of non-operative group will be treated conservatively with intravenous antibiotics (cefuroxime) at surgical ward. Elective cholecystectomy will not be arranged.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Quality of life RAND-36 scores
Quality of life according to RAND-36
Pain scores (0-100)
Pain (VAS, range 0-100)
Number of patients with failure of antibiotic therapy
Recurrent cholecystitis after antibiotic therapy
Time of hospitalization (days)
Length of time at hospital
Mortality (number of patients)
Death within 30 d
Number of patients with complications
Bile duct injury, re-operations, bile leakage, hemorragia, wound infections, pneumonia etc.
Cost analysis in euros
cost analysis comparison between groups
Full Information
NCT ID
NCT02972944
First Posted
November 8, 2016
Last Updated
October 13, 2021
Sponsor
Kuopio University Hospital
Collaborators
Turku University Hospital, Tampere University Hospital, Oulu University Hospital, Mikkeli Central Hospital, North Karelia Central Hospital, Jyväskylä Central Hospital, Päijänne Tavastia Central Hospital, Central Hospital of Hämeenlinna, Central Hospital of Jorvi
1. Study Identification
Unique Protocol Identification Number
NCT02972944
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
Collaborators
Turku University Hospital, Tampere University Hospital, Oulu University Hospital, Mikkeli Central Hospital, North Karelia Central Hospital, Jyväskylä Central Hospital, Päijänne Tavastia Central Hospital, Central Hospital of Hämeenlinna, Central Hospital of Jorvi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cholecystectomy group
Arm Type
Experimental
Arm Description
Cholecystectomy group will undergo laparoscopic cholecystectomy within 48 hrs after randomization.
Arm Title
Non-operative group
Arm Type
Active Comparator
Arm Description
Patients of non-operative group will be treated conservatively with intravenous antibiotics (cefuroxime) at surgical ward. Elective cholecystectomy will not be arranged.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
Non-operative treatment
Primary Outcome Measure Information:
Title
Specific Morbidity Index Scores
Description
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
Secondary Outcome Measure Information:
Title
Quality of life RAND-36 scores
Description
Quality of life according to RAND-36
Time Frame
pre-operatively and 1 year postoperatively
Title
Pain scores (0-100)
Description
Pain (VAS, range 0-100)
Time Frame
pre-operatively, 1 week, 1 month and 1 year postoperatively
Title
Number of patients with failure of antibiotic therapy
Description
Recurrent cholecystitis after antibiotic therapy
Time Frame
1 week, 1 month and 1 year postoperatively
Title
Time of hospitalization (days)
Description
Length of time at hospital
Time Frame
1 month
Title
Mortality (number of patients)
Description
Death within 30 d
Time Frame
1 month
Title
Number of patients with complications
Description
Bile duct injury, re-operations, bile leakage, hemorragia, wound infections, pneumonia etc.
Time Frame
1 week, 1 month and 1 year postoperatively
Title
Cost analysis in euros
Description
cost analysis comparison between groups
Time Frame
1 week, 1 month and 1 year postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannu Paajanen, Professor
Phone
17 173 311
Ext
+358
Email
Hannu.Paajanen@kuh.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Antti Kivivuori, MD
Phone
443516698
Ext
+358
Email
Antti.Kivivuori@esshp.fi
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
State/Province
Pohjois-Savo
ZIP/Postal Code
70200
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuomo Rantanen, Professor
Phone
17 173 311
Ext
+358
Email
Tuomo.Rantanen@kuh.fi
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Laparoscopic Cholecystectomy or Conservative Treatment in the Acute Cholecystitis of Elderly Patients
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