Cholecystitis, AcuteNCT02972944
Laparoscopic Cholecystectomy or Conservative Treatment in the Acute Cholecystitis of Elderly Patients
A study testing Laparoscopic cholecystectomy and Non-operative treatment in people with Cholecystitis, Acute, run by Kuopio University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholecystitis, Acute
- What is being tested?
- Laparoscopic cholecystectomy and Non-operative treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2016to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Radiologically confirmed acute cholecystitis
- Age over 75 yrs
- American Association of Anesthesiologists Classification class 2-3
- Duration of symptoms < 5 days
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Kuopio University Hospital
Kuopio, Northern Savonia, 70200
Tuomo Rantanen, Professor, 17 173 311 ext. +358, Tuomo.Rantanen@kuh.fi
About this study
Official title: Acute Cholecystitis in the Elderly: Comparative Randomized and Cohort Study of Laparoscopic Cholecystectomy vs. Conservative Treatment With Antibiotics Alone
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.
Read the 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.
- Conditions
- Cholecystitis, Acute
- Being tested
- Laparoscopic cholecystectomy, Non-operative treatment
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
Non-operative treatmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Cholecystectomy group | Experimental | Cholecystectomy group will undergo laparoscopic cholecystectomy within 48 hrs after randomization. Receives: Procedure: Laparoscopic cholecystectomy |
| Non-operative group | Active comparator | Patients of non-operative group will be treated conservatively with intravenous antibiotics (cefuroxime) at surgical ward. Elective cholecystectomy will not be arranged. Receives: Procedure: Non-operative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year postoperatively
Secondary outcomes (7)
Quality of life RAND-36 scores
Quality of life according to RAND-36
Measured: pre-operatively and 1 year postoperatively
Pain scores (0-100)
Pain (VAS, range 0-100)
Measured: pre-operatively, 1 week, 1 month and 1 year postoperatively
Number of patients with failure of antibiotic therapy
Recurrent cholecystitis after antibiotic therapy
Measured: 1 week, 1 month and 1 year postoperatively
Time of hospitalization (days)
Length of time at hospital
Measured: 1 month
Mortality (number of patients)
Death within 30 d
Measured: 1 month
Number of patients with complications
Bile duct injury, re-operations, bile leakage, hemorragia, wound infections, pneumonia etc.
Measured: 1 week, 1 month and 1 year postoperatively
Cost analysis in euros
cost analysis comparison between groups
Measured: 1 week, 1 month and 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystitis, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Hannu Paajanen, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972944
- Sponsor's protocol ID
- 326/2016
- Status last verified
- Feb 2021
- First submitted
- 8 Nov 2016
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Cholecystitis in the Elderly: Comparative Randomized and Cohort Study of Laparoscopic Cholecystectomy vs. Conservative Treatment With Antibiotics Alone
- ClinicalTrials.gov ID
- NCT02972944
- Acronym / sponsor ID
- 326/2016
- Conditions
- Cholecystitis, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- 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
- Study start
- Oct 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 25 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecystectomy group | Experimental | Procedure: Laparoscopic cholecystectomyCholecystectomy group will undergo laparoscopic cholecystectomy within 48 hrs after randomization. |
| Non-operative group | Active comparator | Procedure: Non-operative treatmentPatients of non-operative group will be treated conservatively with intravenous antibiotics (cefuroxime) at surgical ward. Elective cholecystectomy will not be arranged. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Radiologically confirmed acute cholecystitis
- Age over 75 yrs
- American Association of Anesthesiologists Classification class 2-3
- Duration of symptoms < 5 days
Key exclusion criteria (7 listed)
- American Association of Anesthesiologists Classification class 4-5
- Age under 75 yrs
- Peritonitis
- Sepsis or septic shock
- Duration of symptoms over 6 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic cholecystectomy | Procedure or surgery | Cholecystectomy group |
| Non-operative treatment | Procedure or surgery | Non-operative group |
Primary outcome
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)
7 secondary outcomes
Quality of life RAND-36 scores
Time frame: pre-operatively and 1 year postoperatively
Pain scores (0-100)
Time frame: pre-operatively, 1 week, 1 month and 1 year postoperatively
Number of patients with failure of antibiotic therapy
Time frame: 1 week, 1 month and 1 year postoperatively
Time of hospitalization (days)
Time frame: 1 month
Mortality (number of patients)
Time frame: 1 month
Number of patients with complications
Time frame: 1 week, 1 month and 1 year postoperatively
Cost analysis in euros
Time frame: 1 week, 1 month and 1 year postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic cholecystectomy and Non-operative treatment in people with Cholecystitis, Acute, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hannu Paajanen, Professor (17 173 311 ext. +358, Hannu.Paajanen@kuh.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific Morbidity Index Scores (time frame: 1 year postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.