Empirical Antibiotics in Acute Inflammatory Gallbladder Disease

NCT04321902 | Unknown

• 1 other identifier: Seoul-08
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystitis, Acute

Keywords

empirical antibiotics; postoperative complication

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Infectious Postoperative Complications

  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.

  30 days

Secondary Outcomes (1)

• Duration of hospitalization

  Participants will be followed for the duration of hospital stay, an expected average of 2 days

Study Arms (2)

The experimental group in acute cholecystitis

EXPERIMENTAL

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 First-generation cephalosporin (Cefazolin inj., 1g, Cefazolin sodium, Chong-geun-dang pharm.co.) was used as before and during surgery.

Procedure: Laparoscopic cholecystectomy

The controled group in acute cholecystitis

EXPERIMENTAL

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 Sencond-generation cephalosporin (Shincef inj., 750mg, Cefuroxime sodium, Shin-poong pharm.co.) was used as before and during surgery.

Procedure: Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomy PROCEDURE

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. 4. Dissection started from Calot's triangle and the operation was performed by retrograde cholecystectomy. 5. The excised gallbladder was placed in a laparoscopic pocket and extracted through the umbilicus. 6. The trocar was removed and the skin was sutured 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)

Also known as: hematology, blood chemistry, urine, blood clotting, and chest x-rays were performed

The controled group in acute cholecystitis; The experimental group in acute cholecystitis

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead

Study Sites (1)

Department of HBP Surgery, Seoul St. Mary's hospital

Seoul, Seocho-gu, Banopo-dong, 137-701, South Korea

Location

MeSH Terms

Conditions

Cholecystitis, Acute; Postoperative Complications

Interventions

Cholecystectomy, Laparoscopic; Hematologic Tests; Blood Chemical Analysis; Urination; Blood Coagulation

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Clinical Chemistry Tests; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Hemostasis; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Sung eun Park, MD

  The Catholic University of Korea

  STUDY DIRECTOR

Central Study Contacts

Tae ho Hong, MD. PhD

CONTACT

+82-10-5206-5266; gshth@catholic.ac.kr

Eun young Kim, MD. PhD

CONTACT

+82-10-4720-0246; freesshs@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: March 25, 2020
• Study Start: April 2, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2021
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)