Acute CholecystitisNCT01548339
Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms
A study testing Laparoscopic cholecystectomy in people with Acute Cholecystitis and Cholecystectomy, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
The purpose of this study is to compare the clinical outcomes of early versus delayed laparoscopic cholecystectomies for acute cholecystitis with more than 72 hours of symptoms. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Cholecystitis, Cholecystectomy
- What is being tested?
- Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2009to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- proven echographic cholecystitis
Who cannot join
- pregnancy
- immunosuppression
- severe sepsis
- perforated cholecystitis
- peritonitis
- cholangitis
- acute pancreatitis
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Lausanne Hospitals
Lausanne, Canton of Vaud, 1011
About this study
Official title: Laparoscopic Cholecystectomy for Acute Cholecystitis: is the Rule of 72 Hours Still Actual?
The purpose of this study is to compare the clinical outcomes of early versus delayed laparoscopic cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.
Read the detailed description
In acute biliary cholecystitis, there was a dogma that patients should be operated within 72 hours of evolution. However, retrospective studies suggested that laparoscopic cholecystectomy even after 72 hours was safe. Moreover, some randomized controlled-trials did not found any differences in term of complications between early and delayed cholecystectomy, however none of these studies did separate patients according to the onset of symptoms. The aim of our present study was to compare the clinical outcomes of immediate versus delayed cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.
- Conditions
- Acute Cholecystitis, Cholecystectomy
- Being tested
- Laparoscopic cholecystectomy
- 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
3 trocars laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Delayed | Active comparator | Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment Receives: Procedure: Laparoscopic cholecystectomy |
| Early | Experimental | Laparoscopic cholecystectomy performed directly after the initial diagnosis Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Event ("Global Morbidity").
any adverse event occurring from time of diagnosis until the 30th postoperative day
Measured: 30 postoperative days
Secondary outcomes (2)
Postoperative Complications
postoperative complications graded according to Clavien classification
Measured: 30 postoperative days
Length of Stay
total in hospital stay
Measured: 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startFeb 2009
- Primary completionFeb 2015
- Study completionOct 2015
Why it stopped: Intermediary analysis showing increased morbidity in the delayed group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute CholecystitisStudies 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas DEMARTINES, University of Lausanne Hospitals
- Investigators
- Nicolas Demartines, MD, Study chair, University of Lausanne HospitalsNermin Halkic, MD, Study director, University of Lausanne HospitalsLuca Di Mare, MD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548339
- Sponsor's protocol ID
- 252/08 CHV
- Status last verified
- Jul 2020
- First submitted
- 5 Mar 2012
- Last updated
- 6 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Roulin D, Saadi A, Di Mare L, Demartines N, Halkic N. Early Versus Delayed Cholecystectomy for Acute Cholecystitis, Are the 72 hours Still the Rule?: A Randomized Trial. Ann Surg. 2016 Nov;264(5):717-722. doi: 10.1097/SLA.0000000000001886.
PubMed 27741006
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Cholecystectomy for Acute Cholecystitis: is the Rule of 72 Hours Still Actual?
- ClinicalTrials.gov ID
- NCT01548339
- Acronym / sponsor ID
- 252/08 CHV
- Conditions
- Acute Cholecystitis, Cholecystectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Intermediary analysis showing increased morbidity in the delayed group
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Posted 25 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the clinical outcomes of early versus delayed laparoscopic cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.
Detailed description
In acute biliary cholecystitis, there was a dogma that patients should be operated within 72 hours of evolution. However, retrospective studies suggested that laparoscopic cholecystectomy even after 72 hours was safe. Moreover, some randomized controlled-trials did not found any differences in term of complications between early and delayed cholecystectomy, however none of these studies did separate patients according to the onset of symptoms. The aim of our present study was to compare the clinical outcomes of immediate versus delayed cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed | Active comparator | Procedure: Laparoscopic cholecystectomyLaparoscopic cholecystectomy performed secondarily after an initial conservative treatment |
| Early | Experimental | Procedure: Laparoscopic cholecystectomyLaparoscopic cholecystectomy performed directly after the initial diagnosis |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- proven echographic cholecystitis
Key exclusion criteria (7 listed)
- pregnancy
- immunosuppression
- severe sepsis
- perforated cholecystitis
- peritonitis
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 cholecystectomy3 trocars laparoscopic cholecystectomy | Procedure or surgery | Delayed, Early |
Primary outcome
Number of Participants With Adverse Event ("Global Morbidity").
Time frame: 30 postoperative days
any adverse event occurring from time of diagnosis until the 30th postoperative day
2 secondary outcomes
Postoperative Complications
Time frame: 30 postoperative days
Length of Stay
Time frame: 30 postoperative days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27741006Roulin D, Saadi A, Di Mare L, Demartines N, Halkic N. Early Versus Delayed Cholecystectomy for Acute Cholecystitis, Are the 72 hours Still the Rule?: A Randomized Trial. Ann Surg. 2016 Nov;264(5):717-722. doi: 10.1097/SLA.0000000000001886.
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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.
Nicolas Demartines, MD study chair
University of Lausanne Hospitals
Nermin Halkic, MD study director
University of Lausanne Hospitals
Luca Di Mare, MD principal investigator
University of Lausanne Hospitals
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 in people with Acute Cholecystitis and Cholecystectomy, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 1 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: stopped early, as of the sponsor's last update on 6 Aug 2020. 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 Switzerland. 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?
Yes. Results are posted in the registry (first posted 25 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Event ("Global Morbidity"). (time frame: 30 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01548339, which also lists 1 linked publication.
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 6 Aug 2020.