Effect Of Early Versus Delayed Laparoscopic Cholecystectomy In Patients With Grade II Cholecystitis
Primary Purpose
Cholecystitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Laparoscopic cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystitis focused on measuring Acute cholecystitis, Laparoscopic cholecystectomy
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
Sites / Locations
- University of Health Sciences Izmir Tepecik Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
early cholecystectomy
delayed cholecystectomy
Arm Description
In early cholecystectomy group after antibiotherapy was started with ceftriaxone and metronidazole, laparoscopic cholecystectomy was performed in the first 7 days following the hospitalization.
Patients who accepted delayed surgery were also given the same antibiotherapy and operated after 6 weeks following their discharge
Outcomes
Primary Outcome Measures
mortality, morbidity and difficult cholecystectomy rates between two groups
effect of the timing on mortality, morbidity and difficult cholecystectomy in patients with acute cholecystitis
Secondary Outcome Measures
Full Information
NCT ID
NCT05352087
First Posted
April 19, 2022
Last Updated
April 23, 2022
Sponsor
Tepecik Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05352087
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 14, 2019 (Actual)
Primary Completion Date
June 14, 2021 (Actual)
Study Completion Date
July 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tepecik Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis
Keywords
Acute cholecystitis, Laparoscopic cholecystectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
early cholecystectomy
Arm Type
Active Comparator
Arm Description
In early cholecystectomy group after antibiotherapy was started with ceftriaxone and metronidazole, laparoscopic cholecystectomy was performed in the first 7 days following the hospitalization.
Arm Title
delayed cholecystectomy
Arm Type
Active Comparator
Arm Description
Patients who accepted delayed surgery were also given the same antibiotherapy and operated after 6 weeks following their discharge
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy
Intervention Description
Laparoscopic cholecystectomy is minimally invasive surgery to remove the gallbladder.
Primary Outcome Measure Information:
Title
mortality, morbidity and difficult cholecystectomy rates between two groups
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Health Sciences Izmir Tepecik Training and Research Hospital
City
Izmir
State/Province
Konak
ZIP/Postal Code
35180
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request
Citations:
PubMed Identifier
29032636
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 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.
Results Reference
result
PubMed Identifier
22872303
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.
Results Reference
result
PubMed Identifier
17704863
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.
Results Reference
result
Learn more about this trial
Effect Of Early Versus Delayed Laparoscopic Cholecystectomy In Patients With Grade II Cholecystitis
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