Effect Of Early Versus Delayed Laparoscopic Cholecystectomy In Patients With Grade II Cholecystitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect Of Early Versus Delayed Laparoscopic Cholecystectomy On Postoperative Mortality, Morbidity and Difficult Cholecystectomy In Patients With Grade II Cholecystitis According To Tokyo 2018 Guidelines: Prospective Randomised Study

Conditions
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Cholecystitis

Intervention / Treatment
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* Procedure: Laparoscopic cholecystectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: early cholecystectomy<br>In early cholecystectomy group after antibiotherapy was started with ceftriaxone and metronidazole, laparoscopic cholecystectomy was performed in the first 7 days following the hospitalization. | Procedure: Laparoscopic cholecystectomy<br>* Laparoscopic cholecystectomy is minimally invasive surgery to remove the gallbladder.<br>|
| Active Comparator: delayed cholecystectomy<br>Patients who accepted delayed surgery were also given the same antibiotherapy and operated after 6 weeks following their discharge | Procedure: Laparoscopic cholecystectomy<br>* Laparoscopic cholecystectomy is minimally invasive surgery to remove the gallbladder.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality, morbidity and difficult cholecystectomy rates between two groups | effect of the timing on mortality, morbidity and difficult cholecystectomy in patients with acute cholecystitis | patients will be followed up to the first 30 day period from discharge. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute cholecystitis, Laparoscopic cholecystectomy