Necessity of Preoperative Empirical Antibiotic Use in Acute Cholecystitis

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Brief Title

Necessity of Preoperative Empirical Antibiotic Use in Acute Cholecystitis

Official Title

Necessity of Preoperative Empirical Antibiotic Use in Mild to Moderate Acute Inflammatory Gallbladder Disease; a Randomized Controlled Trial.

Brief Summary

      In this study, the investigators compared the surgical outcomes according to the type of
      antibiotics before surgery in patients who did not have evidence of systemic infection during
      acute cholecystitis.

      The primary purpose of the study was to determine the type of preoperative antibiotics in
      patients who were scheduled for cholecystectomy, because of the mild (grade I) or moderate
      (grade 2) acute inflammatory gallbladder disease without gallbladder perforation. The
      investigators compared the incidence of postoperative complications according to the types of
      preoperative antibiotics(the first-generation vs second-generation cephalosporin).

      The secondary purpose of the study was to confirm the clinical efficacy of first-generation
      cephalosporins following the use of empirical antibiotics. And the investigators compare with
      postoperative pain, postoperative hospital stay, re-hospitalization, and need for additional
      treatment. In addition, the investigators compare the postoperative complications, such as
      atelectasis and postoperative ileus.
    

Detailed Description

      A. Background

      B. Code name of clinical trial drug or medical device or generic name of main ingredient, raw
      material drug (raw material in case of medical device) and its quantity, formulation (form /
      structure / number in case of medical device), etc

        1. Test drug : normal saline

        2. control drug : Cefazolin inj., 1 g, Cefazolin sodium, white crystal, vial injection with
           crystalline powder or lump

           C. Target disease Acute cholecystitis without evidence of gallbladder perforation among
           mild (Grade I) and severe (Grade II) classification of acute cholecystitis according to
           Tokyo guidelines

           D. Subject selection criteria, exclusion criteria, number of target subjects and their
           rationale

             1. 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

             2. 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)

                  8. Drain tube is required during surgery (eg. if delayed biliary leakage was
                     concerned, hepatic duct injury was suspected or cystic duct ligation was
                     incomplete during operation.)

                E. Calculation and basis of the number of target subjects In the previous studies,
                infectious complications after laparoscopic surgery for acute inflammatory
                gallbladder disease are reported as 2.5%, so it was designed as a non-inferiority
                experiment between the two groups.After assuming power 80% and 2-sided confidence
                level 95%, the dropout rate was 10%. Considering this, 90 people were assigned to
                each group.

                F. Random allocation schedule and operation Randomization was performed using block
                randomization without stratification, and a block size of 2, 4 or 6 was applied to
                complete the randomization table to maintain unpredictability, which was the basic
                principle of randomization. .

                G. Assignment bags with random assignment numbers and assigned groups were made of
                opaque material so that they could be blinded and remain sealed until random
                assignment was performed for each subject.

                H. The person in charge of the clinical trial or the person in charge of the
                clinical trial finally checked the exclusion criteria and, if it was a suitable
                subject, a random number was assigned and stored in the allocation bag. Thereafter,
                the management pharmacist receives the assignment bag with the assignment number,
                releases the seal of the assignment bag, and prescribes antibiotics according to
                the administration group assigned to the subject according to each random
                assignment number. Afterwards, the managed pharmacist brought the antibiotics
                according to the newly developed drug code for the clinical trial in accordance
                with the [Medical Clinical Trial Management Standards (related to Article 30,
                Paragraph 1)], and then administered to the patient. The management pharmacist
                should record the release information (release date and releaser) immediately after
                the release of the assignment bag which the random assignment enveloped, when it
                had already been released once, it could not reassign the randomization code to
                other subjects even if the subject withdraws consent.

                I. Clinical trial method (administration / dosage, administration / use method,
                administration / use period, combination therapy, etc.)

                  1. Research Design Prospective randomized controlled trial in two groups

                  2. Describe what treatment is performed for the experimental group / control
                     group A. Clinical trial flow

                  1. Before the patient's surgery, hematology, blood chemistry, blood coagulation,
                     urine, Chest X-ray, EKG, and Abdomen CT were performed in accordance with
                     current clinical practice guidelines.

                  2. Select the patient group that met the diagnostic criteria according to the
                     test results above.

                  3. Select a random patient group to determine the type of empirical antibiotic to
                     use before surgery

                  4. For each selected group, intravenous antibiotics (Cefazolin inj., 1 g,
                     Cefazolin sodium versus. normal saline) were used as before surgery.

                     - The clinical trial manager or the clinical trial manager finally checked the
                     criteria for selection exclusion and, if it was a suitable subject, a random
                     number was assigned and stored in the allocation bag. Thereafter, the
                     management pharmacist received the assignment bag with the assignment number,
                     released the seal of the assignment bag, and prescribed antibiotics according
                     to the administration group assigned to the subject according to each random
                     assignment number. Afterwards, the managed pharmacist brought the antibiotics
                     according to the newly developed drug code for the clinical trial in
                     accordance with the [Medical Clinical Trial Management Standards (related to
                     Article 30, Paragraph 1)], and then administered to the patient.

                  5. After surgery, both groups were discharged through the same recovery process
                     after surgery.

                  6. On the 1st day after surgery, hematology, blood chemistry, urine, blood
                     clotting, and chest x-rays were performed. (Inspection and treatment were
                     performed according to the current clinical pathway of gallbladder surgery)

                  7. If there are no specifics, a fluid diet was performed starting from lunch on
                     the first day after surgery.

                  8. If there were no specifics, patient would be discharged on the second day
                     after surgery.

                  9. Stability and effectiveness were monitored during hospitalization and after
                     discharge.

                B. 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
                     ligated with a 10mm clip as well.

                     - If the cystic duct was unstablely ligated, ligation was performed through an
                     endoloop.

                     - 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.
                     C. Discharge Principle

                  1. When hematologically stable and vital signs were stable

                  2. When the patient's condition was stable by proceeding to the normal diet

                J. characteristics of observational and clinical test 

                1) Medical history investigation Before entering the clinical trial, checked the
                following items through interviews, chart and questions about the subject's
                background (demographic information), medical history, etc., and recorded them in
                the record.

                (1) Background investigation: Subject's initials, date of birth, sex, feasibility
                of pregnancy, pregnancy, lactation (2) medical history (3) History history: History
                of other diseases 2) Physical examination, vital signs examination Investigators
                checked whether the body organs were normal or abnormal through medical examination
                and examination and any significant findings found during the examination should be
                recorded in the physical examination column of the record sheet, and confirmed to
                be suitable for participation in the study.

                After surgery, the pain level was measured by questioning the patient himself using
                the VAS score, and the amount of analgesics (injection drugs; tramadol and oral
                drugs; ircodon) administered after surgery to the patient was recorded through
                medication records.

                3) Clinical examination

                It was performed during the hospitalization after decision to perform
                cholecystectomy. Blood sampling for the subjects was performed aseptically.
                Investigators recorded the test results, determined whether they were normal or
                abnormal, and record the opinions of researchers regarding abnormal values.
                Clinical tests included :

                  1. Hematology tests: Hematocrit, Hemoglobin, MCV, MCH, MCHC, Platelet, WBC &
                     Differential count, ESR

                  2. Blood coagulation test: PT INR, aPTT, BT

                  3. Blood chemistry test: SGOT (AST), SGPT (ALT), alkaline phosphatase, γ-GTP,
                     bilirubin (total / direct), fasting plasma glucose, BUN, creatinine, sodium,
                     potassium, chloride, calcium, phosphorus, magnesium , total protein, albumin,
                     uric acid, CPK, LDH, free fatty acid, CRP, HbA1c, CRP

                  4. Urine test: Color, specific gravity, pH, Leucocytes, Nitrite, Protein,
                     Glucose, Ketone, Urobilinogen, Bilirubin, Microscopy (RBC, WBC) 4) Imaging
                     medical examination

                  1. Before surgery, chest X-ray and electrocardiography were performed to evaluate
                     whether surgery was possible.

                  2. Imaging studies such as CT, Sonogram, and MRCP were conducted. 5)
                     Postoperative hospital stay The day after surgery, hematology, blood
                     chemistry, urine, blood clotting, Chest x-ray.

                6) Check for infection.

                  -  Surgical site infection

             1. Confirmation at every patient visit. Troca insertion site was defined as
                superficial surgical site infection if there was redness, heat sensation and
                abscess.

             2. If there was fluid retention and abscess around the surgical site in the abdominal
                cavity, it was defined as deep surgical site infection.

                - Distant infection

                  -  Respiratory, urinary system infections and bacteremia or lymphangitis 7) Check
                     for leakage of bile.

                       -  Groups who had drainage catheter would be checked through the drainage
                          pattern. In the group without drainage catheter, after surgery, if there
                          is epigastric pain, indigestion, fever, and jaundice, a selective medical
                          imaging test (CT, sonogram, MRCP) was performed.

                          8) Surgery time, bleeding amount were described. 9) Postoperative
                          complications (things other than those described above) were described.

                K. Predicted side effects and precautions

                  1. Side effects that might occur in the experimental group (the first-generation
                     cephalosporin use group)

                       -  Wound infections and deep infections : Since antibiotics were used, the
                          possibility was very low.

                       -  Side effects of antibiotics (allergic reaction)

                  2. Side effects that could be occurred in the control group (2nd generation
                     cephalosporin use group)

                       -  Extension of the period of stay

                       -  Increased hospitalization costs

                       -  Increase of multi-drug resistant bacteria

                       -  Side effects of antibiotics (allergic reaction) (In the event of side
                          effects, medical judgment was used to actively select a therapeutic
                          method.)

                L. Stop or drop the test Dosing and testing should be discontinued if any of the
                following occurs, and the reasons for discontinuation and findings should be
                recorded.

                  1. After surgery, when a side effect that was life-threatening, the investigator
                     determined that it was necessary to stop

                  2. When the patient refused or withdrew consent after starting the test

                  3. If the patient was inadequate after starting the test

                  4. After the start of the test, if patient had received treatment that might
                     affect the course of treatment, such as other combination drugs and herbal
                     treatments, without the permission of the test manager

                  5. After the start of the test, it was judged that it was impossible to conduct
                     inspection or investigation due to the circumstances

                  6. After surgery, when surgery was required due to a disease of another organ not
                     related to gallbladder surgery.

                M. Statistical analysis

                  1. Analysis of validity variables A. Analysis of primary efficacy variables.

                       -  During the postoperative hospital stay, the incidence of wound infection
                          and deep infection rates in the group using the first-generation
                          cephalosporin and normal saline as an empirical antibiotic before surgery
                          was determined by the student's t-test or according to the satisfaction
                          of the normal distribution assumption. Test using wilcoxn's rank sum
                          test, and present the descriptive statistics (average, standard
                          deviation, median, minimum, and maximum). Also, the difference in the
                          incidence of infection between the two groups (test group-control group)
                          was presented as the mean and 95% confidence interval, and if it was less
                          than the non-inferiority limit of 13%, the group using the
                          first-generation cephalosporin antibiotics was the second-generation
                          cephalosporin. It was not inferior to the group using antibiotics. That
                          was, it would decide that it was not inferior.

                     B. Complications after surgery.

                       -  Complications will be defined and analyzed through researchers'
                          experience and review of existing literature.

                            -  Fever after surgery: Fever of 37.5 ° C or more that lasts at least
                               48 hours after surgery.

                               ② Surgical site infection: In case of seroma, hematoma, or abscess
                               in the surgical incision.

                               ③ Surgery wound wound: When the wound was opened and opened.

                               ④ Coming, vomiting after surgery: If patient needed to use
                               antiemetic after 24 hours of surgery, or if patient had vomited even
                               once.

                               ⑤ Sustained shoulder pain after surgery: If patient complained of a
                               stiff shoulder until the outpatient follow-up examination (one week
                               after discharge).

                               ⑥ Bleeding after surgery: When the patient's vital signs change or
                               there was a decrease in Hb 2.0 or higher on the hemoglobin test the
                               day after surgery.

                                 -  Abscess in the abdominal cavity after surgery: When an abscess
                                    in the abdominal cavity was confirmed by image examination
                                    (ultrasound, CT, etc.) accompanied by fever and pain in the
                                    physical examination.

                                      -  Persistent bowel obstruction: If the meal could not be
                                         started even after 2 days of surgery.

                  2. Analysis of secondary efficacy variables 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, and the normality test was performed to test
                     with Student's t-test for normal distribution, and for the non-normal
                     distribution, Wilcoxon rank-sum test The difference between the two groups
                     would be tested. All statistical analysis would use SPSS version 21.0, and it
                     would be judged that it was statistically significant below the significance
                     level of 0.05.

                  3. Analysis target group

                  1. intention to treat analysis group Randomization would be performed only if the
                     selection criteria described above were met, and all randomized subjects would
                     be included in statistical analysis.

                  2. per protocol analysis group The Per protocol analysis group was defined as a
                     patient who had undergone randomization and had undergone chest imaging the
                     next day after surgery, and whose pain had been assessed.

                4) How to deal with missing values This study was a prospective study, and it was
                expected that there would be no missing values of the main or secondary endpoints
                during the experiment. However, if a missing value occurred, the missing value was
                substituted with the average value.

                5) How to deal with compliance Since the intervention applied to this study was an
                intervention performed during surgery while the patient had general anesthesia,
                there would be no difference in treatment compliance. In addition, postoperative
                thoracic imaging and pain assessment were also included in the clinical pathway for
                laparoscopic cholecystectomy, so there was no difference in treatment compliance.

                N. Safety evaluation of side effects and reporting method In the event of adverse
                reactions and adverse reactions after surgery, trained the subject to report to the
                researcher, checked and recorded the occurrence of adverse reactions at each visit,
                symptoms, appearance time, duration, severity of adverse reactions, and causal
                relationship with the test drug Record in the report. In the event of a serious
                adverse event or unexpected problem, the responsible researcher should report it to
                the clinical trial.

                O. Compensation Protocol of victim Laparoscopic cholecystectomy was a safe
                operation with a very low risk of surgery. Also, there are basically no additional
                risks accompanying the study. Antibiotics were drugs that had been used before, so
                there are no additional complications beyond the known complications. If patient
                got injury or illness by participating in this study, medical treatment would be
                provided. In order to receive medical treatment related to the clinical symptoms or
                signs, investigators would make a quick diagnosis and receive treatment when needed
                through consultation.
    


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

180

Start Date

March 2, 2021

Completion Date

December 30, 2021

Primary Completion Date

September 30, 2021

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

NCT04661371

Organization ID

Seoul-S9


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

December 2020