Cholecystitis
Conditions
Keywords
Acute cholecystitis, Laparoscopic cholecystectomy
Brief summary
The timing ofthe cholecystectomy in patients with acute cholecystitis is still controversial. In our study, we aimed toinvestigate the effect of early and delayed cholecystectomy on difficultcholecystectomy, morbidity and mortality in patients diagnosed with Grade IIcholecystitis according to Tokyo 2018 guidelines.
Detailed description
The timing ofthe cholecystectomy in patients with acute cholecystitis is still controversial. In our study, we aimed toinvestigate the effect of early and delayed cholecystectomy on difficultcholecystectomy, morbidity and mortality in patients diagnosed with Grade II cholecystitis according to Tokyo 2018 guidelines. Patients that applied to the emergency department and diagnosed with Grade II acute cholecystitis between December 2019 and June 2021 were included in this study. Cholecystectomy was performed within 7 days and 6 weeks after symptom onset. The effect of early and delayed cholecystectomy was observed. The study is single-centered and the patient group graded as Grade II according to the Tokyo 2018 guideline acute cholecystitis diagnostic criteria will be included in the study. Patients will decide on the treatment method to be applied with their consent. The patients will be divided into two groups as those operated in the early period (first 7 days) and those operated in the late period (\>6 weeks). The parameters to be compared were the rate of conversion from laparoscopic to open, bile duct injury and bile leakage rate, grade II-III complication rate in the Clavien Dindo complication scoring system, morbidity rate in the first 30 days postoperatively, and difficult cholecystectomy rate based on intraoperative imaging findings according to the Parkland scoring system. The research will be terminated when the number of 120 patients determined by the power analysis result is reached. Chi-square and Student's t test will be used for the statistical evaluation of the results of the patients, respectively, for quantitative and continuous variables, and Mann-Whitney U test (two samples) or Kruskal-Wallis test (more than two samples) will be used for the analysis of abnormally distributed variables.
Interventions
PROCEDURELaparoscopic cholecystectomy
Laparoscopic cholecystectomy is minimally invasive surgery to remove the gallbladder.
Sponsors
Tepecik Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Grade II cholecystitis according to Tokyo 2018 guidelines * Patients older than 18 years of age
Exclusion criteria
* Patients younger than 18 years of age * Patients diagnosed with choledocholithiasis * Patients with Grade I or Grade III cholecystitis * Pregnancy * Patients unable to comply with the treatment or who could not consent to the treatment due to their mental state * Patients that refused the treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mortality, morbidity and difficult cholecystectomy rates between two groups | patients will be followed up to the first 30 day period from discharge. | effect of the timing on mortality, morbidity and difficult cholecystectomy in patients with acute cholecystitis |
Countries
Turkey (Türkiye)
Outcome results
None listed