An interventional study of Laparoscopic cholecystectomy in Cholecystitis, sponsored by Tepecik Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-28.
Sponsored by Tepecik Training and Research Hospital · Not applicable, Interventional, and Treatment
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.
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.
272 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.
This study's enrollment of 92 is close to the median of 87 across 172 interventional studies indexed under Cholecystitis.
Browse Cholecystitis studies →Tepecik Training and Research Hospital is the lead sponsor of 32 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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
Patients who accepted delayed surgery were also given the same antibiotherapy and operated after 6 weeks following their discharge
Procedure: Laparoscopic cholecystectomy
Laparoscopic cholecystectomy is minimally invasive surgery to remove the gallbladder.
mortality, morbidity and difficult cholecystectomy rates between two groups
effect of the timing on mortality, morbidity and difficult cholecystectomy in patients with acute cholecystitis
Time frame: patients will be followed up to the first 30 day period from discharge.
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Plan to share: No — The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request
Ran from Dec 2019 to primary completion in Jun 2021, 18 months.
Of 79 non-industry interventional studies with no phase under Cholecystitis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 26. This study's 18 months is close to that.
Counting every sponsor, half of 85 studies reached it within 18 months; a quarter within 9 and three quarters within 26.
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Tepecik Training and Research Hospital