Acute CholecystitisREWONCT02796443
The Real World of Acute Cholecystitis
An observational study of Acute Cholecystitis, run by Asklepios Klinik Langen.
Trial summary
Meta-analysis of randomized controlled trials and population based studies in acute cholecystitis are in favor for early laparoscopic surgery versus a delayed operation several weeks later. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Cholecystitis
- What is being tested?
- Laparoscopic cholecystectomy (LC)
- Type of treatment
- Surgery or procedure
- How many people
- 1,729 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to May 2016
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All cholecystectomized patients
Who may be able to join
- All patients with cholecystectomies
Who cannot join
- No exclusion criteria
About this study
Official title: When Results of Randomised Controlled Trials and Population Based Studies do Not Reflect the Real World: A Cohort Study in Acute Cholecystitis
Meta-analysis of randomized controlled trials and population based studies in acute cholecystitis are in favor for early laparoscopic surgery versus a delayed operation several weeks later. The main problems in these studies are the exclusion criteria used, thus not reflecting the real world setting of acute cholecystitis. The purpose of this study is to demonstrate that a delayed laparoscopic cholecystectomy in a real world scenario has no worse outcome in comparison with an early operation (within 72 hours after onset of symptoms).
Read the detailed description
Background:
Randomized controlled trials (RCTs) and population based studies are in favor of an early operation in acute cholecystitis (1, 2). Thus, one of the largest RCT so far, demonstrated significant more complications in a group of delayed cholecystectomy. The main problems in these studies are the exclusion criteria used, ie severe cases are not considered.
Objective:
In a cohort study all cholecystectomy patients are analysed to demonstrate that delayed laparoscopic cholecystectomy (DLC) in a real world setting has a less complication rate than early cholecystectomy (ELC).
Setting:
Academic Teaching Hospital with 400 beds, seven departments (anesthesiology and intensive care medicine, orthopaedics and trauma surgery, visceral and thoracic surgery, gastroenterology, cardiology, gynecology and obstetrics, psychiatry. The visceral and thoracic department has a main focus on minimally invasive techniques.
Participants:
All cholecystectomy patients during 1/2006 and 9/2015
Variables:
Clavien Dindo Complication score, American Society of Anaesthesiologist (ASA) Score, conversion rate, onset of symptoms, histology, hospital stay
Data sources:
Chart analyses
- Conditions
- Acute Cholecystitis
- Being tested
- Laparoscopic cholecystectomy (LC)
- Keywords
- acute cholecystitis, early versus delayed surgery
- 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 cholecystectomy (LC)Procedure or surgery
Removal of the gallbladder via a minimally invasive approach
| Study group | Role | What they receive |
|---|---|---|
| Early laparoscopic cholecystectomy (ELC) | Operation within 72 hours after onset of symptoms Receives: Procedure: Laparoscopic cholecystectomy (LC) | |
| Intermediate cholecystectomy (ILC) | Operation within 14 days after onset of symptoms Receives: Procedure: Laparoscopic cholecystectomy (LC) | |
| Delayed LC (DLC) | Operation after 6-12 weeks Receives: Procedure: Laparoscopic cholecystectomy (LC) | |
| Elective laparoscopic cholecystectomy | Biliary colic with no acute cholecystitis Receives: Procedure: Laparoscopic cholecystectomy (LC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clavien-Dindo-Complication Score
During the hospital stay after Operation, which is usually between 3 and 6 days, all complications according to the Clavien-Dindo-Complication Score, are recorded.
Measured: 3-6 days
Secondary outcomes (1)
Conversion rate
How often is the laparoscopic approach changed to the open procedure.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJan 2006
- Primary completionSep 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,729 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asklepios Klinik Langen
- Sponsor type
- University, hospital or other
- Collaborators
- Goethe University
- Responsible party
- Principal investigator, Prof. Dr. Dr. Ernst Hanisch, Asklepios Klinik Langen
- Investigators
- Ernst W Hanisch, Prof Dr Dr, Principal investigator, Asklepios Klinik Langen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796443
- Sponsor's protocol ID
- AKLangen
- Acronym
- REWO
- Status last verified
- Jul 2019
- First submitted
- 1 Jun 2016
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be published on www.dkmic.de
Publications
Gutt CN, Encke J, Koninger J, Harnoss JC, Weigand K, Kipfmuller K, Schunter O, Gotze T, Golling MT, Menges M, Klar E, Feilhauer K, Zoller WG, Ridwelski K, Ackmann S, Baron A, Schon MR, Seitz HK, Daniel D, Stremmel W, Buchler MW. Acute cholecystitis: early versus delayed cholecystectomy, a multicenter randomized trial (ACDC study, NCT00447304). Ann Surg. 2013 Sep;258(3):385-93. doi: 10.1097/SLA.0b013e3182a1599b.
PubMed 24022431de Mestral C, Rotstein OD, Laupacis A, Hoch JS, Zagorski B, Alali AS, Nathens AB. Comparative operative outcomes of early and delayed cholecystectomy for acute cholecystitis: a population-based propensity score analysis. Ann Surg. 2014 Jan;259(1):10-5. doi: 10.1097/SLA.0b013e3182a5cf36.
PubMed 23979286
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- When Results of Randomised Controlled Trials and Population Based Studies do Not Reflect the Real World: A Cohort Study in Acute Cholecystitis
- ClinicalTrials.gov ID
- NCT02796443
- Acronym / sponsor ID
- REWO / AKLangen
- Conditions
- Acute Cholecystitis
- Keywords
- acute cholecystitis, early versus delayed surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,729 participants (actual)
- Lead sponsor
- Asklepios Klinik LangenUniversity, hospital or other
- Collaborators
- Goethe University
- Study start
- Jan 2006
- Primary completion
- Sep 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 10 Jun 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.
Meta-analysis of randomized controlled trials and population based studies in acute cholecystitis are in favor for early laparoscopic surgery versus a delayed operation several weeks later. The main problems in these studies are the exclusion criteria used, thus not reflecting the real world setting of acute cholecystitis. The purpose of this study is to demonstrate that a delayed laparoscopic cholecystectomy in a real world scenario has no worse outcome in comparison with an early operation (within 72 hours after onset of symptoms).
Detailed description
Background:
Randomized controlled trials (RCTs) and population based studies are in favor of an early operation in acute cholecystitis (1, 2). Thus, one of the largest RCT so far, demonstrated significant more complications in a group of delayed cholecystectomy. The main problems in these studies are the exclusion criteria used, ie severe cases are not considered.
Objective:
In a cohort study all cholecystectomy patients are analysed to demonstrate that delayed laparoscopic cholecystectomy (DLC) in a real world setting has a less complication rate than early cholecystectomy (ELC).
Setting:
Academic Teaching Hospital with 400 beds, seven departments (anesthesiology and intensive care medicine, orthopaedics and trauma surgery, visceral and thoracic surgery, gastroenterology, cardiology, gynecology and obstetrics, psychiatry. The visceral and thoracic department has a main focus on minimally invasive techniques.
Participants:
All cholecystectomy patients during 1/2006 and 9/2015
Variables:
Clavien Dindo Complication score, American Society of Anaesthesiologist (ASA) Score, conversion rate, onset of symptoms, histology, hospital stay
Data sources:
Chart analyses
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early laparoscopic cholecystectomy (ELC) | – | Procedure: Laparoscopic cholecystectomy (LC)Operation within 72 hours after onset of symptoms |
| Intermediate cholecystectomy (ILC) | – | Procedure: Laparoscopic cholecystectomy (LC)Operation within 14 days after onset of symptoms |
| Delayed LC (DLC) | – | Procedure: Laparoscopic cholecystectomy (LC)Operation after 6-12 weeks |
| Elective laparoscopic cholecystectomy | – | Procedure: Laparoscopic cholecystectomy (LC)Biliary colic with no acute cholecystitis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All cholecystectomized patients
Key inclusion criteria (1 listed)
- All patients with cholecystectomies
Key exclusion criteria (1 listed)
- No exclusion criteria
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 (LC)Removal of the gallbladder via a minimally invasive approach | Procedure or surgery | Delayed LC (DLC), Early laparoscopic cholecystectomy (ELC), Elective laparoscopic cholecystectomy, Intermediate cholecystectomy (ILC) |
Primary outcome
Clavien-Dindo-Complication Score
Time frame: 3-6 days
During the hospital stay after Operation, which is usually between 3 and 6 days, all complications according to the Clavien-Dindo-Complication Score, are recorded.
1 secondary outcome
Conversion rate
Time frame: Intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Background: PubMed 24022431Gutt CN, Encke J, Koninger J, Harnoss JC, Weigand K, Kipfmuller K, Schunter O, Gotze T, Golling MT, Menges M, Klar E, Feilhauer K, Zoller WG, Ridwelski K, Ackmann S, Baron A, Schon MR, Seitz HK, Daniel D, Stremmel W, Buchler MW. Acute cholecystitis: early versus delayed cholecystectomy, a multicenter randomized trial (ACDC study, NCT00447304). Ann Surg. 2013 Sep;258(3):385-93. doi: 10.1097/SLA.0b013e3182a1599b.
- Background: PubMed 23979286de Mestral C, Rotstein OD, Laupacis A, Hoch JS, Zagorski B, Alali AS, Nathens AB. Comparative operative outcomes of early and delayed cholecystectomy for acute cholecystitis: a population-based propensity score analysis. Ann Surg. 2014 Jan;259(1):10-5. doi: 10.1097/SLA.0b013e3182a5cf36.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be published on www.dkmic.de
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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.
Ernst W Hanisch, Prof Dr Dr principal investigator
Asklepios Klinik Langen
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cholecystitis, run by Asklepios Klinik Langen.
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 1 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: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clavien-Dindo-Complication Score (time frame: 3-6 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 NCT02796443, which also lists 2 linked publications.
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 26 Jul 2019.