Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04744441
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2021-01-25
Brief Title:
Mortality Risk Estimation in Acute Calculous Cholecystitis Beyond the Tokyo Guidelines
Sponsor:
Hospital del Mar
Organization:
Hospital del Mar
Study Overview
Official Title:
Mortality Risk Estimation in Acute Calculous Cholecystitis Beyond the Tokyo Guidelines
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACME
Brief Summary:
Acute calculous cholecystitis ACC is the second most frequent surgical condition in emergency departments the complication rate of ACC is 20-55 and the mortality rate is 05-15 in recent series The Tokyo Guidelines TG advocate for different 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 mortality in ACC and compare them with TG classification
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 andor 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 CholecystitisPersistent 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 v12 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 normal distribution of the quantitative variables was assessed using the Kolmogorov-Smirnov test which showed that none of the variables were normally distributed therefore their values were expressed as median and interquartile ranges The Mann-Whitney U non-parametric test was used to assess the significance of differences between means
The association between qualitative variables was assessed with the chi-square test or Fishers exact test as required The increased risk of an event associated with a variable was reported as the odds ratio OR and 95 confidence interval CI
As this was a retrospective observational study and the treatment groups were markedly asymmetric we used the propensity score matching method to select and compare two subgroups of patients evenly balanced by severity according to the TG18 criteria and by comorbidity according to the Charlson Comorbidity Index
A model for predicting mortality was built using binomial logistic regression with stepwise progressive conditional entry and standard baseline conditions for admission and rejection of variables with significant differences in the univariate 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
The objective of the study is to identify the risk factors for mortality in ACC and compare them with TG classification
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 andor 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 CholecystitisPersistent 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 v12 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 normal distribution of the quantitative variables was assessed using the Kolmogorov-Smirnov test which showed that none of the variables were normally distributed therefore their values were expressed as median and interquartile ranges The Mann-Whitney U non-parametric test was used to assess the significance of differences between means
The association between qualitative variables was assessed with the chi-square test or Fishers exact test as required The increased risk of an event associated with a variable was reported as the odds ratio OR and 95 confidence interval CI
As this was a retrospective observational study and the treatment groups were markedly asymmetric we used the propensity score matching method to select and compare two subgroups of patients evenly balanced by severity according to the TG18 criteria and by comorbidity according to the Charlson Comorbidity Index
A model for predicting mortality was built using binomial logistic regression with stepwise progressive conditional entry and standard baseline conditions for admission and rejection of variables with significant differences in the univariate 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None