Acute Calculous CholecystitisNCT05135299
Complications in Acute Calculous Cholecystitis
An observational study of Acute Calculous Cholecystitis, run by Hospital del Mar.
Trial summary
Acute calculous cholecystitis (ACC) is the second most frequent surgical condition in emergency departments, the complication rate of ACC is 8-20%, and the mortality rate is 0.5-6% in recent series. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Calculous Cholecystitis
- How many people
- 963 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Apr 2021
- 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 patients admited with a diagnostic of Acute Cholecystitis in a dedicated surgical emergency unit, from January 2011 to December 2016, in a Metropolitan University Hospital in Barcelona, Spain.
Who may be able to join
- Diagnostic of a "Pure" Acute Calculous Cholecystitis.
- Older than 18 years old.
Who cannot join
- Younger than 18 years old.
- Any concomitant diagnostic that could change the prognostic of a "Pure" ACC, for example: Cholangitis, Pancreatitis, Postoperative ACC, Acalculous cholecystitis.
About this study
Acute calculous cholecystitis (ACC) is the second most frequent surgical condition in emergency departments, the complication rate of ACC is 8-20%, and the mortality rate is 0.5-6% in recent series. The Tokyo Guidelines (TG) advocate for different risk factors and initial treatments of ACC with no clear evidence that all patients will benefit from them.
The objective of the study is to identify the risk factors for complications in ACC.
Read more
It is a retrospective cohort study conducted from January 2011 to December 2016 in a single center with a dedicated surgical emergency unit in a Metropolitan University Hospital in Barcelona, Spain. The analysis of the data was finished in March 2020.
The study candidates comprised 963 consecutive patients with a diagnosis of ACC according to the TG18 and/or received a diagnosis of ACC in the Pathology report in those that an emergent cholecystectomy was performed.
The study case definition was a 'Pure Acute Cholecystitis' (pure ACC); therefore, patients with any other concomitant diagnosis potentially influencing outcome (Postoperative cholecystitis, Acute Cholangitis, Acute Pancreatitis, Incidental Cholecystectomy, Acalculous Cholecystitis, Chronic Cholecystitis/Persistent Colic, Post-endoscopic retrograde pancreato-cholangiography, or Neoplasia) were excluded from the final analysis.
Variables:
Primary data were available from a prospective database maintained in File Maker v.12 (Mountainview, CA, USA), which included basic demographic data, type of interventions, sex, days of admission, and complications. Every record was completed by browsing the electronic patient record, adding laboratory and microbiology data, as well as antibiotic therapy, duration of procedure, additional procedures, and grade of acute cholecystitis according to the TG18 diagnostic criteria.
Preoperative comorbidities were assessed using the Charlson Comorbidity Index and surgical risk by ASA classification. The type of initial treatment was classified as Surgical Treatment (Cholecystectomy either by laparoscopy or laparotomy) or Non-Surgical Treatment, which was either percutaneous cholecystostomy or intravenous antibiotics alone.
The main outcome measure was the mortality after the diagnostic of ACC. In the patients that were discharged, 30 days after the diagnosis, if the patients was not discharged in 30 days, at any time during the same admission.
Interventions:
All patients received intravenous antibiotic therapy from the moment the diagnosis was formulated, according to a fixed protocol.
Ultrasound-guided cholecystostomy was performed percutaneously with an 8-Fr catheter (SKATER ™, Argon Medical Devices, Rochester, NY, USA) by either transhepatic or transperitoneal insertion, at the discretion of the radiologist.
Laparoscopic Cholecystectomy was performed according to the French technique using 4 trochars. The content of the gallbladder was evacuated by Veress needle puncture when necessary.
Statistical Analysis:
The discrimination power of the model was assessed by receiver operating characteristic (ROC) curves and was compared with the DeLong method.
Legal and Ethical considerations This study was approved by the clinical research ethical committee of the Hospital del Mar and was classified as a non-clinical trial.
- Conditions
- Acute Calculous Cholecystitis
- Keywords
- Emergent Cholecystectomy, Mortality in acute cholecystitis, High Risk Patient, Morbidity in Acute Cholecystitis, Risk Factors in Acute Cholecystitis, Unfit for Surgery, Acute Cholecystitis, Acute Calculous Cholecystitis
- Medical subject headings
- Cholecystitis, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients withs complications after diagnosis of Acute Calculous Cholecystitis
The main outcome measure was the total of complications in patients with an Acute Calculous Cholecystitis assessed by the Clavien-Dindo Classification.
Measured: 2011-2016
Description of the risk factors for complications with the demographic data
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the gender (Male/Female)
Measured: 2011-2016
Description of the risk factors for complications with the demographic data
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the age in years.
Measured: 2011-2016
Description of the risk factors for complications with the physiological parameters
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the temperature in Celsius.
Measured: 2011-2016
Description of the risk factors for complications with the physiological parameters
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the blood pressure in mmHg.
Measured: 2011-2016
Description of the risk factors for complications with the physiological parameters
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the cardiac rate in bpm.
Measured: 2011-2016
Description of the risk factors for complications with the physiological parameters
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the respiratory rate in bpm.
Measured: 2011-2016
Description of the risk factors for complications with the laboratory test
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the bilirubin in mg/dL.
Measured: 2011-2016
Description of the risk factors for complications with the laboratory test
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the creatinine in mg/dL.
Measured: 2011-2016
Description of the risk factors for complications with the laboratory test
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the alkaline phosphatase in U/L.
Measured: 2011-2016
Description of the risk factors for complications with the laboratory test
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the gamma-glutamyl-transferase in U/L.
Measured: 2011-2016
Description of the risk factors for complications with the laboratory test
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the glutamyl oxaloacetic transaminase in U/L.
Measured: 2011-2016
Description of the risk factors for complications with the laboratory test
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the protrombine Time-INR.
Measured: 2011-2016
Description of the risk factors for complications with the laboratory test
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the lactate in gr/dL.
Measured: 2011-2016
Description of the risk factors for complications with the laboratory test
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the White Blood Cell count.
Measured: 2011-2016
Description of the risk factors for complications with the laboratory test
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the partial oxygen pressure in mmHg.
Measured: 2011-2016
Description of the risk factors for complications with the laboratory test
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the C-Reactive Protein in gr/dL.
Measured: 2011-2016
Description of the risk factors for complications with the laboratory test
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the platelets count.
Measured: 2011-2016
Description of the risk factors for complications with the grade of severity of ACC following the TG18
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the following variables:
- Grade I or Mild ACC
- Grade II or Moderate ACC
- Grade III or Severe ACC
Measured: 2011-2016
Description of the risk factors for complications with the grade of severity of ACC following the Charlson Comorbidity Index
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the following the charlson comorbidity index in two groups: above 6 and below 6.
Measured: 2011-2016
Description of the risk factors for complications with the ASA Classification
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the following the charlson comorbidity index in two groups:
- Group I and II
- Group III and IV
Measured: 2011-2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study startJan 2011
- Primary completionDec 2016
- Study completionApr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Calculous 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
- 963 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana María González Castillo, Hospital del Mar
- Investigators
- Ana María González-Castillo, M.D., Principal investigator, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135299
- Sponsor's protocol ID
- Complications in ACC
- Status last verified
- Nov 2021
- First submitted
- 14 May 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all primary and secondary variables of anonymized individual data set will be provided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications in Acute Calculous Cholecystitis
- ClinicalTrials.gov ID
- NCT05135299
- Acronym / sponsor ID
- Complications in ACC
- Conditions
- Acute Calculous Cholecystitis
- Keywords
- Emergent Cholecystectomy, Mortality in acute cholecystitis, High Risk Patient, Morbidity in Acute Cholecystitis, Risk Factors in Acute Cholecystitis, Unfit for Surgery, Acute Cholecystitis, Acute Calculous Cholecystitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 963 participants (actual)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 26 Nov 2021 (actual)
- 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.
Acute calculous cholecystitis (ACC) is the second most frequent surgical condition in emergency departments, the complication rate of ACC is 8-20%, and the mortality rate is 0.5-6% in recent series. The Tokyo Guidelines (TG) advocate for different risk factors and initial treatments of ACC with no clear evidence that all patients will benefit from them.
The objective of the study is to identify the risk factors for complications in ACC.
It is a retrospective cohort study conducted from January 2011 to December 2016 in a single center with a dedicated surgical emergency unit in a Metropolitan University Hospital in Barcelona, Spain. The analysis of the data was finished in March 2020.
The study candidates comprised 963 consecutive patients with a diagnosis of ACC according to the TG18 and/or received a diagnosis of ACC in the Pathology report in those that an emergent cholecystectomy was performed.
The study case definition was a 'Pure Acute Cholecystitis' (pure ACC); therefore, patients with any other concomitant diagnosis potentially influencing outcome (Postoperative cholecystitis, Acute Cholangitis, Acute Pancreatitis, Incidental Cholecystectomy, Acalculous Cholecystitis, Chronic Cholecystitis/Persistent Colic, Post-endoscopic retrograde pancreato-cholangiography, or Neoplasia) were excluded from the final analysis.
Variables:
Primary data were available from a prospective database maintained in File Maker v.12 (Mountainview, CA, USA), which included basic demographic data, type of interventions, sex, days of admission, and complications. Every record was completed by browsing the electronic patient record, adding laboratory and microbiology data, as well as antibiotic therapy, duration of procedure, additional procedures, and grade of acute cholecystitis according to the TG18 diagnostic criteria.
Preoperative comorbidities were assessed using the Charlson Comorbidity Index and surgical risk by ASA classification. The type of initial treatment was classified as Surgical Treatment (Cholecystectomy either by laparoscopy or laparotomy) or Non-Surgical Treatment, which was either percutaneous cholecystostomy or intravenous antibiotics alone.
The main outcome measure was the mortality after the diagnostic of ACC. In the patients that were discharged, 30 days after the diagnosis, if the patients was not discharged in 30 days, at any time during the same admission.
Interventions:
All patients received intravenous antibiotic therapy from the moment the diagnosis was formulated, according to a fixed protocol.
Ultrasound-guided cholecystostomy was performed percutaneously with an 8-Fr catheter (SKATER ™, Argon Medical Devices, Rochester, NY, USA) by either transhepatic or transperitoneal insertion, at the discretion of the radiologist.
Laparoscopic Cholecystectomy was performed according to the French technique using 4 trochars. The content of the gallbladder was evacuated by Veress needle puncture when necessary.
Statistical Analysis:
The discrimination power of the model was assessed by receiver operating characteristic (ROC) curves and was compared with the DeLong method.
Legal and Ethical considerations This study was approved by the clinical research ethical committee of the Hospital del Mar and was classified as a non-clinical trial.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admited with a diagnostic of Acute Cholecystitis in a dedicated surgical emergency unit, from January 2011 to December 2016, in a Metropolitan University Hospital in Barcelona, Spain.
Key inclusion criteria (2 listed)
- Diagnostic of a "Pure" Acute Calculous Cholecystitis.
- Older than 18 years old.
Key exclusion criteria (2 listed)
- Younger than 18 years old.
- Any concomitant diagnostic that could change the prognostic of a "Pure" ACC, for example: Cholangitis, Pancreatitis, Postoperative ACC, Acalculous cholecystitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients withs complications after diagnosis of Acute Calculous Cholecystitis
Time frame: 2011-2016
The main outcome measure was the total of complications in patients with an Acute Calculous Cholecystitis assessed by the Clavien-Dindo Classification.
Description of the risk factors for complications with the demographic data
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the gender (Male/Female)
Description of the risk factors for complications with the demographic data
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the age in years.
Description of the risk factors for complications with the physiological parameters
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the temperature in Celsius.
Description of the risk factors for complications with the physiological parameters
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the blood pressure in mmHg.
Description of the risk factors for complications with the physiological parameters
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the cardiac rate in bpm.
Description of the risk factors for complications with the physiological parameters
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the respiratory rate in bpm.
Description of the risk factors for complications with the laboratory test
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the bilirubin in mg/dL.
Description of the risk factors for complications with the laboratory test
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the creatinine in mg/dL.
Description of the risk factors for complications with the laboratory test
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the alkaline phosphatase in U/L.
Description of the risk factors for complications with the laboratory test
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the gamma-glutamyl-transferase in U/L.
Description of the risk factors for complications with the laboratory test
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the glutamyl oxaloacetic transaminase in U/L.
Description of the risk factors for complications with the laboratory test
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the protrombine Time-INR.
Description of the risk factors for complications with the laboratory test
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the lactate in gr/dL.
Description of the risk factors for complications with the laboratory test
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the White Blood Cell count.
Description of the risk factors for complications with the laboratory test
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the partial oxygen pressure in mmHg.
Description of the risk factors for complications with the laboratory test
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the C-Reactive Protein in gr/dL.
Description of the risk factors for complications with the laboratory test
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the platelets count.
Description of the risk factors for complications with the grade of severity of ACC following the TG18
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the following variables: * Grade I or Mild ACC * Grade II or Moderate ACC * Grade III or Severe ACC
Description of the risk factors for complications with the grade of severity of ACC following the Charlson Comorbidity Index
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the following the charlson comorbidity index in two groups: above 6 and below 6.
Description of the risk factors for complications with the ASA Classification
Time frame: 2011-2016
We will study the increased risk of an event associated with a variable reported as the Odds Ratio (OR) and 95% confidence interval (CI) of the following the charlson comorbidity index in two groups: * Group I and II * Group III and IV
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 Nov 2021.
- Individual participant dataSharing planned: Yes. all primary and secondary variables of anonymized individual data set will be provided
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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.
Ana María González-Castillo, M.D. principal investigator
Hospital del Mar
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Calculous Cholecystitis, run by Hospital del Mar.
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 2 inclusion and 2 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 Nov 2021. 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?
Number of patients withs complications after diagnosis of Acute Calculous Cholecystitis (time frame: 2011-2016). The study lists 21 primary outcomes in all. 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 26 Nov 2021.