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NCT Number: NCT05352087

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Izmir Tepecik Training and Research Hospital

Izmir, Konak, 35180, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic cholecystectomy

Procedure

Laparoscopic cholecystectomy is minimally invasive surgery to remove the gallbladder.

Primary outcomes

  1. mortality, morbidity and difficult cholecystectomy rates between two groups

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Tepecik Training and Research Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 28, 2022
Registry last updated
Apr 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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