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

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

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.

Study Overview

• Status: Completed
• Conditions: Cholecystitis
• Intervention / Treatment: Procedure: Laparoscopic cholecystectomy

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
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konak
    • Izmir, Konak, Turkey, 35180
      • University of Health Sciences Izmir Tepecik Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: early cholecystectomy; 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; Laparoscopic cholecystectomy is minimally invasive surgery to remove the gallbladder.
ACTIVE_COMPARATOR: delayed 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Tepecik Training and Research Hospital

Publications and helpful links

General Publications

• 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 Y, Hibi T, Jagannath P, Jonas E, Liau KH, Dervenis C, Gouma DJ, Cherqui D, Belli G, Garden OJ, Gimenez ME, de Santibanes E, Suzuki K, Umezawa A, Supe AN, Pitt HA, Singh H, Chan ACW, Lau WY, Teoh AYB, Honda G, Sugioka A, Asai K, Gomi H, Itoi T, Kiriyama S, Yoshida M, Mayumi T, Matsumura N, Tokumura H, Kitano S, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):41-54. doi: 10.1002/jhbp.515. Epub 2018 Jan 9.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 14, 2019
• Primary Completion (ACTUAL): June 14, 2021
• Study Completion (ACTUAL): July 14, 2021

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: April 23, 2022
• First Posted (ACTUAL): April 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 23, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Laparoscopic cholecystectomy; Acute cholecystitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Acalculous Cholecystitis
• Other Study ID Numbers: 1/134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No