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

Learn more about:
Related Clinical Trial
Subserosal Laparoscopic Cholecystectomy Influence of Gut Microbiome in Gallstone Disease Erector Spinae Plane Block as a Rescue Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy Elective Endoscopic Gallbladder Treatment: Pilot Study Use of Indocyanine Green in Acute Cholecystitis Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Inoperable Acute Cholecystitis Diagnostic Performance of Low-Dose CT for Acute Abdominal Conditions Factors Affecting The Recurrence Of Acute Cholecystitis After Treatment With Percutaneous Cholecystostomy M-Tapa Block vs External Oblique Intercostal Block for Laparoscopic Cholesistectomy Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy. Norwegian Randomized Trial on Indocyanine Green Cholangiography Utility for Laparoscopic Cholecystectomy, Prestudy A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients Effect Of Early Versus Delayed Laparoscopic Cholecystectomy In Patients With Grade II Cholecystitis Effectiveness of Empirical Antibiotic Use in Mild to Moderate Acute Inflammatory Gallbladder Disease ENDOSCOPIC ULTRASONOGRAPHY (EUS) GUIDED GALLBLADDER DRAINAGE WITH TWO MONTHS STENT REMOVAL FOR ACUTE CHOLECYSTITIS: A PROSPECTIVE STUDY The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy M-Tapa Block for Laparoscopic Cholesistectomy The Comparison of Hemodynamic Effects Between Remimazolam-remifentanil and Propofol-remifentanil in Patients Undergoing Laparoscopic Cholecystectomy Impact of Percutaneous Cholecystostomy in the Management of Acute Cholecystitis. Indocyanine Green Fluorescent Cholangiography and Intraoperative Angiography With Laparoscopic Cholecystectomy Fetal Outcomes Among Pregnant Emergency General Surgery Patients Usefulness of the CADISS® System for the Cleavage of Severe Adhesions in Cholecystectomy SPY Fluorescence Imaging Systems and Indocyanine Green as a Tool for Developing Intelligent Peri-Operative Imaging Early Laparoscopic Cholecystectomy Versus Percutaneous Cholecystostomy in Grade II Acute Cholecystitis Guidelines Validation and Comparison of Scores for Prediction of RIsk for Post-operative Major Morbidity After Cholecystectomy in Acute Calculous Cholecystitis (SPRIMACC) GB34 Acupuncture in Acute Cholecystitis Low Dose ICG for Biliary Tract and Tumor Imaging Visualization of the Extrahepatic biliaRy Tree Trial Gallbladder Cryoablation in High-Risk Patients Hong Kong Follow up Protocol After EUS Gallbladder Drainage for Acute Cholecistitis Bikini Scarless Laparoscopic Cholecystectomy for Morbid Obesity as a Day Case. Naldebain for Pain Management of Laparoscopic Cholecystectomy Operative vs Non-Operative Management of Acute Appendicitis and Acute Cholecystitis in COVID-19 Positive Patients Acute Cholecystitis With Concomitant Choledocholithiasis: Unicentric Study of Prevalence and Predictive Factors Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate Necessity of Preoperative Empirical Antibiotic Use in Acute Cholecystitis Safety and Feasibility of ActivSightTM in Human Indocyanine Green to Visualize Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis in the Elderly: A Retrospective Study. A Scoring System for Difficult Laparoscopic Cholecystectomy RISK FACTORS FOR NECROTIC CHOLECYSTITIS DURING COVID-19 PANDEMIC: THE ChoCO WSES PROSPECTIVE MULTICENTER OBSERVATIONAL STUDY Evaluation of a Protocol for Multidisciplinary Management of Acute Cholecystitis. How to Predict Postoperative Complications After Early Laparoscopic Cholecystectomy for Acute Cholecystitis: the Chole-Risk Score Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis Prognostic Indicators as Provided by the EPIC ClearView WSES International Register of Emergency Surgery Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI) Cefoperazone/Sulbactam In The Treatment Of Serious Intra-Abdominal And Hepatobiliary Infections. Prospective Validation of “Cholecystectomy First” Strategy for Gallstone Migration ONSD According to the Position During Laparoscopy Risk of Umbilical Trocar-site Hernia After SILC Cholecystectomy Versus Conventional Cholecystectomy Drainage or Not for Laparoscopic Cholecystetomy UDCA for Symptomatic Gallstone Disease Small-incision Open Cholecystectomy or Laparoscopic Cholecystectomy for Gallbladder Disease Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection Transvaginal Cholecystectomy Using Endoscopic Assistance Doripenem in the Treatment of Complicated Intra-Abdominal Infections Doripenem in the Treatment of Complicated Intra-Abdominal Infections The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy No Need for Neuromuscular Blockade in Daycase Laparoscopic Surgery Efficacy of Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy on a Virtual Reality Simulator Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy Evaluation of PC 6 “Neiguan” With Conventional Acupuncture to Prevent PONV After Laparoscopic Cholecystectomy. Role of the Right Portal Pedicle and Rouviere’s Sulcus as an Anatomic Landmark in Laparoscopic Cholecystectomy DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Multi-center Study Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection. NOTES-Assisted Laparoscopic Cholecystectomy Surgery EUS-guided Transenteric Drainage With a Novel Lumen-apposing Metal Stent Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy Fluorescence Cholangiography During Cholecystectomy – a RCT Outcome of IV Acetaminophen Use in Laparoscopic Cholecystectomies in Patients at Risk of OSA FALCON: a Multicenter Randomized Controlled Trial Cholecystectomy First vs Sequential Common Bile Duct Imaging + Cholecystectomy Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy 3D Versus 4K Laparoscopic Cholecystectomy Laryngeal Mask Airway Supreme Versus the Tracheal Tube as an Airway Device in Elective Laparoscopic Cholecystectomy Effect of Modified Stylet Angulation on the Intubation With GlideScope® Evaluation of Closed-loop TIVA Propofol, Sufentanil and Ketamine Guided by BIS Monitor BDD With UDCA Therapy After Laparoscopic Cholecystectomy Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy Postoperative Pain Results According to Pressure to Form Pneumoperitoneum Benefits of Glycopyrrolate on Intubation With Rigid-videostylet (OptiScope®) Prediction of Postoperative Pain by Injection Pain of Propofol Transient ECG Changes in Patients With Acute Biliary Disease Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy Establishing Visualization Grading Scale on LESS Cholecystectomy Improving Informed Consent Process for Percutaneous Cholecystostomy in the Emergency Department Natural Orifice Transgastric Endoscopic Surgical Removal of the Gallbladder Anesthesia With Propofol, Dexmedetomidine and Lidocaine Infusions for Laparoscopic Cholecystectomy A Clinical Study of Chinese Domestic Surgical Robot Laparoscopic Cholecystectomy: Study of Left Side of Laparoscopic Cholecystectomy Tracheal Intubation in Patient With Semi-rigid Collar Immobilization of the Cervical Spine: A Comparison of Fiberoptic Bronchoscope Assisted With Pentax-airway Scope and Fiberoptic Bronchoscope Alone Effect of Intraoperative Nefopam on Acute Pain After Remifentanil Based Anesthesia Ultrasound Guided Subcostal Transversus Abdominis Plane Versus Paravertebral Block in the Laparoscopic Cholecystectomy Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy Effects of Drainage in Laparoscopic Cholecystectomy Observation vs Early Removal of LAMS in EUS Guided Cholecystoenterostomy Study of Pain Perception Between Males and Females Following Laparoscopic Cholecystectomy Drainage is Not Necessary Procedure After Laparoscopic Cholecystectomy Due to Severe Acute Cholecystitis Comparison of Morbidity After Laparoscopic Cholecystectomy for Acutely Inflamed Gall Bladder With and Without Drain Early Versus Delayed Cholecystectomy If Chronic Gallbladder Diseases Increase the Incidence of PEC Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery Use of Robotics for Cholecystectomy; Retrospective Review of Outcomes, Set Up and Learning Curves Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy — Use in Acute Cholecystitis Sub-Study The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy Enhanced Recovery in Laparoscopic Cholecystectomy Empirical Antibiotics in Acute Inflammatory Gallbladder Disease Primary EUS-GBD in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement. Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms Bile Aspiration vs Drain in Acute Cholecystitis Interest of Intravenous Cholangiography With Indocyanine Green in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis Fluorescent Cholangiography During Acute Cholecystitis Reduction of Operating Time by a Smoke Electroprecipitation Device for Acute Cholecystitis Piperacllin Versus Placebo in Patients Undergoing Surgery for Acute Cholecystitis Ultrasonically Activated Scalpel Versus Electrocautery Based Dissection in Acute Cholecystitis Trial Is it Fair to Use Antibiotics After Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder? Percutaneous Transhepatic Cholangiography (PTHC) in Acute Cholecystitis and Clinical Outcomes Acute Cholecystitis – Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy Scoring System in Acute Calculous Cholecystitis Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days? Fast Track Pathway to Accelerated Cholecystectomy Laparoscopic Cholecystectomy or Conservative Treatment in the Acute Cholecystitis of Elderly Patients Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (GLA) Acute Cholecystitis: Early Versus Delayed Laparoscopic Cholecystectomy; Randomized Prospective Study Short Term Outcomes of Acute Cholecystitis Managed at a University Hospital Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis EUS-guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis. A Feasibility Study. Prospective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients A Randomized Controlled Trial on EGBD vs PC for Acute Cholecystitis. Magnetic Resonance Cholangiography and Intraoperative Cholangiography in Acute Cholecystitis The Role of Ultrasound in Cholecystitis AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy in Acute Cholecystitis The Real World of Acute Cholecystitis Functional MRC With Eovist for Acute Cholecystitis FDG-PET/CT in the Evaluation of Patients With Suspected Cholecystitis

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