Clinical trial NCT05352087: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystitis
Keywords: Acute cholecystitis
Laparoscopic cholecystectomy
Lead sponsor: Tepecik Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: mortality, morbidity and difficult cholecystectomy rates between two groups
timeFrame: patients will be followed up to the first 30 day period from discharge.
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: University of Health Sciences Izmir Tepecik Training and Research Hospital
state: Konak
Study officials:
References:
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citation: Yokoe M, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Gomi H, Pitt HA, Gouma DJ, Garden OJ, Buchler MW, Kiriyama S, Kimura Y, Tsuyuguchi T, Itoi T, Yoshida M, Miura F, Yamashita Y, Okamoto K, Gabata T, Hata J, Higuchi R, Windsor JA, Bornman PC, Fan ST, Singh H, de Santibanes E, Kusachi S, Murata A, Chen XP, Jagannath P, Lee S, Padbury R, Chen MF; Tokyo Guidelines Revision Committee. New diagnostic criteria and severity assessment of acute cholecystitis in revised Tokyo Guidelines. J Hepatobiliary Pancreat Sci. 2012 Sep;19(5):578-85. doi: 10.1007/s00534-012-0548-0.
citation: Borzellino G, Sauerland S, Minicozzi AM, Verlato G, Di Pietrantonj C, de Manzoni G, Cordiano C. Laparoscopic cholecystectomy for severe acute cholecystitis. A meta-analysis of results. Surg Endosc. 2008 Jan;22(1):8-15. doi: 10.1007/s00464-007-9511-6. Epub 2007 Aug 18.