Brief Title
Effect Of Early Versus Delayed Laparoscopic Cholecystectomy In Patients With Grade II Cholecystitis
Official Title
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
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.
Study Type
Interventional
Primary Outcome
mortality, morbidity and difficult cholecystectomy rates between two groups
Condition
Cholecystitis
Intervention
Laparoscopic cholecystectomy
Study Arms / Comparison Groups
early cholecystectomy
Description: In early cholecystectomy group after antibiotherapy was started with ceftriaxone and metronidazole, laparoscopic cholecystectomy was performed in the first 7 days following the hospitalization.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
92
Start Date
December 14, 2019
Completion Date
July 14, 2021
Primary Completion Date
June 14, 2021
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Turkey
Location Countries
Turkey
Administrative Informations
NCT ID
NCT05352087
Organization ID
1/134
Responsible Party
Principal Investigator
Study Sponsor
Tepecik Training and Research Hospital
Study Sponsor
, ,
Verification Date
April 2022