Results of Surgical Management According to the Type of Empirical Antibiotics in Acute Inflammatory Gallbladder Disease; a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Seoul St. Mary's Hospital
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Number of Participants with Infectious Postoperative Complications
Study Overview
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
- Background In the case of acute cholecystitis, in which acute inflammation was manifested in patients with gallstones and was accompanied by pain and fever, cholecystectomy through surgery was the standard treatment, and the use of empirical antibiotics to treat inflammation and prevent exacerbation until surgery was performed It was essential. However, as to which antibiotics were used as empirical antibiotics before cholecystectomy among various types of antibiotics, a variety of first-generation cephalosporins or second-generation cephalosporins had been selected and used depending on the existing practice or a physician's supervision. There was insufficient objective research and rationale for the selection of these empirical antibiotics. In addition, the use of high-grade antibiotics that are not required (eg, second-generation cephalosporins) might lead to prolonged hospital stays, wasted medical resources, increased medical expenses, and the occurrence of multi-drug resistant bacteria. In fact, the second-generation cephalosporin antibiotics had a price that was about two to four times higher depending on the product than the first-generation cephalosporin antibiotics. Therefore, in the use of empirical antibiotics before surgery for acute inflammatory gallbladder disease, if the same anti-inflammatory effect and postoperative results could be obtained with the first-generation cephalosporin antibiotics, there was no need to use expensive high-grade antibiotics required as empirical antibiotics before surgery. Moreover, side effects which could caused by high-grade antibiotics would be prevented.
Therefore, in this study, the investigators tried to determine the effective and rational type of empirical antibiotics through random comparison experiments of two groups of patients according to the type of empirical antibiotics used in laparoscopic surgery in patients with acute cholecystitis without evidence of systemic infection. In addition, a double-blind prospective randomized control study comparing the first-generation and second-generation cephalosporin antibiotics commonly used in practice in clinical practice had not been published in Korea, and its clinical usefulness was expected to be great. 2. 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.
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Test drug ; Cefazolin inj., 1 g, Cefazolin sodium, white crystal, vial injection with crystalline powder or lump
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control drug ; Shincef inj., 750mg, Cefuroxime sodium, colorless transparent vial injection with light yellow powder
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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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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, under 70 years of age
Exclusion Criteria
- •patients with elective gallbladder surgery (chronic cholecystitis)
- •gallbladder disease not inflammatory disease (GB cancer, GB polyp)
- •pregnant women, patients under 18 years of age, over 70 years of age
- •patients with simultaneous surgery due to other organ diseases
- •immunosuppressed patients; liver transplant patients, kidney transplant patients, acquired immunodeficiency syndrome patients
- •patients with hemorrhagic tendency, or with hematologic diseases
- •Patients who underwent percutaneous cholecystectomy (PTGBD)
- •Patients with acute cholecystitis who had gallbladder perforation, grade II or III by Tokyo guidelines
Arms & Interventions
The experimental group in acute cholecystitis
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
First-generation cephalosporin (Cefazolin inj., 1g, Cefazolin sodium, Chong-geun-dang pharm.co.) was used as before and during surgery.
Intervention: Laparoscopic cholecystectomy (Procedure)
The controled group in acute cholecystitis
- 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
Sencond-generation cephalosporin (Shincef inj., 750mg, Cefuroxime sodium, Shin-poong pharm.co.) was used as before and during surgery.
Intervention: Laparoscopic cholecystectomy (Procedure)
Outcomes
Primary Outcomes
Number of Participants with Infectious Postoperative Complications
Time Frame: 30 days
Incidence of infectious postoperative complications in patients who underwent a laparoscopic cholecystectomy due to grade I Tokyo guidelines for acute cholecystitis or grade II Tokyo guidelines for acute cholecystitis except the evidence of gallbladder perforation, with the first-generation cephalosporin and the second-generation cephalosporin.
Secondary Outcomes
- Duration of hospitalization(Participants will be followed for the duration of hospital stay, an expected average of 2 days)
Investigators
Taeho Hong
Professor
Seoul St. Mary's Hospital