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

Cholecystitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05352087
• Other study ID #: 1/134
• Status: Completed
• Phase: N/A
• Start date: December 14, 2019
• Est. completion date: July 14, 2021

Study information

• Verified date: April 2022
• Source: Tepecik Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: July 14, 2021
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholecystitis

Intervention

Procedure:
• Laparoscopic cholecystectomy
Laparoscopic cholecystectomy is minimally invasive surgery to remove the gallbladder.

Locations

Country	Name	City	State
Turkey	University of Health Sciences Izmir Tepecik Training and Research Hospital	Izmir	Konak

Sponsors (1)

Lead Sponsor	Collaborator
Tepecik Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Epub 2007 Aug 18. Review. — View Citation

Yokoe M, Hata J, Takada T, Strasberg SM, Asbun HJ, Wakabayashi G, Kozaka K, Endo I, Deziel DJ, Miura F, Okamoto K, Hwang TL, Huang WS, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Noguchi Y, Shikata S, Ukai T, Higuchi R, Gabata T, Mori Y, Iwashita — View Citation

Yokoe M, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Gomi H, Pitt HA, Gouma DJ, Garden OJ, Büchler 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, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.