Effectiveness of Empirical Antibiotic Use in Mild to Moderate Acute Inflammatory Gallbladder Disease

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Brief Title

Effectiveness of Empirical Antibiotic Use in Mild to Moderate Acute Inflammatory Gallbladder Disease

Official Title

Necessity and Effectiveness of Empirical Antibiotic Use in Mild to Moderate Acute Inflammatory Gallbladder Disease; a Multicenter, Double-blind, Randomized, Placebo-controlled Trial

Brief Summary

      This clinical trial is an exploratory clinical trial that evaluates the necessity and
      effectiveness of empirical antibiotic use in mild and moderate acute inflammatory gallbladder
      diseases that require surgery, and the incidence of postoperative infection-related
      complications is compared.
    

Detailed Description

      Cholecystectomy is the standard treatment for acute cholecystitis, accompanied by pain and
      fever due to acute inflammation in cholelithiasis patients. Empirical antibiotics are
      generally used to treat inflammation and prevent exacerbation before and after surgery.
      According to a previous study that confirmed the use of empirical antibiotics (JAMA.
      2014;312(2):145-154. doi:10.1001/jama.2014.7586), the incidence of infectious complications
      was 15% in the group that used empirical antibiotics, and 15% of those who did not use
      empirical antibiotics The incidence of infectious complications in the group was 17%,
      confirming that there was no significant difference between the two groups. Based on these
      results, it was confirmed that the use of antibiotics after surgery was not clinically
      effective in reducing postoperative complications of infection.

      However, there is a lack of objective research and evidence on the efficacy of empirical
      antibiotic use, and the use of antibiotics that have not been proven in practice may lead to
      the extension of hospital stay, waste of medical resources, and an increase in medical
      expenses. In addition, it can cause the occurrence of multidrug-resistant bacteria, which has
      been revived due to many problems recently, so caution is required in its use.

      If the same anti-inflammatory effect and postoperative results can be obtained only through
      surgical treatment in mild and moderate acute inflammatory gallbladder disease, it is
      expected that the indiscriminate use of antibiotics will be reduced, and side effects thereof
      will be prevented. Therefore, this study intends to determine the effective and rational use
      of antibiotics through randomized clinical trials according to empirical antibiotics in
      laparoscopic surgery for patients with acute cholecystitis without evidence of systemic
      infection. In addition, a multicenter, double-blind, prospective, randomized,
      placebo-controlled clinical trial according to the use of empirical antibiotics has not been
      conducted in Korea so far, and thus clinical usefulness is expected to be great.

      study population

        1. Inclusion criteria

             -  19 years old or older - less than 70 years old

             -  Those with mild (grade I by Tokyo guidelines) and severe (Grade Ⅱ) acute
                cholecystitis among the acute cholecystitis patient group

             -  Cholecystitis with adhesions with surrounding organs due to gallbladder wall
                thickness of 4 mm or more or gallbladder inflammation

             -  Those who voluntarily sign the written consent form after hearing and understanding
                the explanation of this clinical trial

        2. Exclusion criteria

             -  Those who are scheduled for elective gallbladder surgery (chronic cholecystitis,
                etc.)

             -  Gallbladder disease that is not an inflammatory disease (GB cancer, GB polyp)

             -  Pregnant or lactating women

             -  A person who performs surgery at the same time due to other organ diseases

             -  Those with immune suppression and bleeding tendency

             -  Those who underwent percutaneous biliary drainage (PTGBD) before surgery

             -  Those who require drainage tube installation during surgery

             -  Those who are hypersensitive to cephalosproline antibiotics

             -  Those who participated in other clinical trials within 3 months before screening

             -  Other investigators who are judged inappropriate to participate in this clinical
                trial

        3. Target number of subjects and calculation basis Since this study was a comparison with a
           reference drug, the number of subjects was calculated using a non-inferiority test. To
           calculate the number of study subjects, in the existing literature, the incidence of
           surgical site infection was 15% in the group using antibiotics and 17% in the group not
           using antibiotics. The difference value of the ratio between the two groups was 2%
           larger in the test group than in the control group, and the study subjects were
           calculated assuming 11%, the upper limit of the confidence interval between the two
           groups, as the non-inferiority margin. As a result, 166 subjects in each group are
           required, 10%. If the dropout rate is calculated, 185 per group, a total of 370
           subjects, is required.

      Study design

        1. Design of clinical trials This clinical trial is an exploratory clinical trial
           evaluating the safety and effectiveness of using empirical antibiotics in mild and
           moderate acute inflammatory gallbladder disease requiring surgery. After determining
           whether the selection/exclusion criteria are suitable on the day of surgery, only
           suitable subjects are randomly assigned to the test group and control group in a 1:1
           ratio. For the control group, the clinical investigational drug (Cefazolin 1g) was
           administered through an intravenous injection within 1 hour before the surgical site
           incision so that the concentration of antibiotics could be sufficiently maintained at
           the time of incision at the surgical site and the test group was administered with
           physiological saline without antibiotics do. Empirical antibiotics and saline are
           administered repeatedly at 24-hour intervals from the first dose until the patient is
           discharged.

           On the day of operation (OP day) and discharge, adverse reaction investigations,
           laboratory tests, and physical examinations for safety and efficacy evaluation are
           performed to evaluate the postoperative pain level and hospitalization period. One week
           after discharge, an outpatient visit is performed to evaluate adverse reactions,
           laboratory tests, and physical examinations to evaluate postoperative pain, the
           occurrence of postoperative infection-related complications, complications other than
           infection, and the need for additional procedures. In addition, when visiting the
           emergency room due to infection-related complications within a month after discharge,
           evaluate and compare the degree of postoperative pain, readmission, complications other
           than infection, and the need for additional procedures.

        2. Method of subject registration and randomization Subjects who have listened to the
           explanation of this clinical trial and agreed to voluntarily participate in the trial
           will be given a subject identification code in the order in which they signed the
           consent form at the screening visit. Randomization is performed to ensure the scientific
           validity of clinical trials by ensuring that the subjectivity of the investigator is not
           involved in the assignment.

      Block randomization is performed to divide the patients into 2 groups and allocate them in a
      1:1 ratio for patients who satisfy the selection/exclusion criteria and agree to participate
      in the clinical trial. For randomization, a statistician independent of this clinical trial
      generates a randomization number using SAS ver.9.4 for Microsoft Windows (SAS Institute Inc,
      NC, Cary, USA) or higher and assigns them sequentially.

      Method of operation

        1. Surgery was started under general anesthesia

        2. A trocar of 10 mm was placed on the navel, 5 mm under the blade, and 5 mm trocar was
           placed on the right upper abdomen.

        3. Pneumoperitoneum was performed using CO2 gas in the abdominal cavity.

             -  Double pressure through CO2 gas was maintained at 12mmHg / and 2L / min.

        4. Dissection started from Calot's triangle, and the operation was performed by retrograde
           cholecystectomy.

             -  The cystic duct was ligated with a 10mm clip, and the cystic artery was also
                ligated with a 10mm clip.

             -  If the cystic duct was unstably ligated, ligation was performed through an end
                loop.

             -  After ligation, the gallbladder was dissected from the liver.

        5. Washed the surgical site.

        6. The excised gallbladder was placed in a laparoscopic pocket and extracted through the
           umbilicus.

        7. The trocar was removed, the skin was sutured, and the operation was completed.

      characteristics of observational and clinical test

        -  Hematology tests: Hematocrit, Hemoglobin, Platelet, WBC & Differential count

        -  Blood coagulation test: PT INR, aPTT, BT

        -  Blood chemistry test: SGOT (AST), SGPT (ALT), alkaline phosphatase, γ-GTP, bilirubin
           (total / direct), fasting plasma glucose, BUN, creatinine, sodium, potassium, chloride,
           total protein, albumin, uric acid, CPK, LDH, CRP

        -  Imaging medical examination

        -  Postoperative hospital stay

        -  Check for infection.

        -  Check for leakage of bile.

        -  Surgery time and bleeding amount were described.

        -  Postoperative complications

      Statistical analysis In the case of categorical variables for the length of stay, surgical
      time, and complication data obtained as secondary endpoints, n (%) was presented, and the
      ratio difference between the two groups was tested using Chi-square or Fisher's exact test.
      In addition, for continuous variables, the mean, standard deviation, median, minimum, and
      maximum values were presented. The normality test was performed to test with Student's t-test
      for normal distribution and the non-normal distribution Wilcoxon rank-sum test. The
      difference between the two groups would be tested. All statistical analyses would use SPSS
      version 21.0, and it would be judged that it was statistically significant below the
      significance level of 0.05.
    


Study Type

Interventional


Primary Outcome

Number of Participants with Infectious Postoperative Complications

Secondary Outcome

 Duration of hospitalization

Condition

Cholecystitis, Acute

Intervention

Laparoscopic cholecystectomy

Study Arms / Comparison Groups

 The experimental group in acute cholecystitis
Description:  inclusion criteria
among patients with mild acute cholecystitis (grade I by Tokyo guidelines) or moderate acute cholecystitis without evidence of gallbladder perforation(grade II)
cholecystitis with a thickness of 4 mm or more on gallbladder in preoperative imaging
Gallbladder with surrounding organs due to gallbladder inflammation
Patients over 19 years of age
normal saline (Isotonic Sodium Chloride Injection Daihan(50mL/bag)) was used before surgery.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

370

Start Date

May 1, 2022

Completion Date

April 30, 2024

Primary Completion Date

April 30, 2023

Eligibility Criteria

        Inclusion Criteria:

          1. among patients with mild acute cholecystitis (grade I by Tokyo guidelines) or moderate
             acute cholecystitis without evidence of gallbladder perforation(grade II)

          2. cholecystitis with a thickness of 4 mm or more on gallbladder in preoperative imaging

          3. Gallbladder with surrounding organs due to gallbladder inflammation

          4. Patients over 19 years of age, under 70 years of age

        Exclusion Criteria:

          1. patients with elective gallbladder surgery (chronic cholecystitis)

          2. gallbladder disease not inflammatory disease (GB cancer, GB polyp)

          3. pregnant women, patients under 18 years of age, over 70 years of age

          4. patients with simultaneous surgery due to other organ diseases

          5. immunosuppressed patients; liver transplant patients, kidney transplant patients,
             acquired immunodeficiency syndrome patients

          6. patients with hemorrhagic tendency, or with hematologic diseases

          7. Patients who underwent percutaneous cholecystectomy (PTGBD)
      

Gender

All

Ages

19 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Sung eun Park, MD, +82-10-5206-5266, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT05339282

Organization ID

Seoul_S10


Responsible Party

Principal Investigator

Study Sponsor

Seoul St. Mary's Hospital


Study Sponsor

Sung eun Park, MD, Study Director, The Catholic University of Korea


Verification Date

May 2022