The Role of Antibiotic Treatment in Patients With Acute Mild Cholecystitis - A Prospective Randomized Controlled Trial

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00557453
First received: November 11, 2007
Last updated: July 12, 2010
Last verified: April 2010
  Purpose

The treatment of acute cholecystitis includes limited oral intake, antibiotics and early or delayed surgery. To date there are no randomized trials proving the benefit of antibiotic treatment.

The aim of this study is to prospectively and randomly compare between patients that are admitted for acute cholecystitis and treated with or without antibiotics.


Condition Intervention
Acute Cholecystitits
Drug: Antibiotic treatment
Drug: No antibiotics

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Role of Antibiotic Treatment in Patients With Acute Mild Cholecystitis - A Prospective Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 120
Study Start Date: April 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
Antibiotic treatment
Drug: Antibiotic treatment
Cefuroxime 750mg X3/d, Ampicillin 2G X4/d, Flagyl 500mg X3/d, Augmentin 1G X3/d, Gentamycin 240mg X1/d, Clindamycin 600mg X3/d, Ciprofloxacin 400mg X2/d All drugs will be administered IV until clinical improvement.
B
Non antibiotic treatment
Drug: No antibiotics
Allowed medications for both groups will include PPI / H2 blockers, home medication, SC insulin for diabetes, and SC clexane if indicated.

Detailed Description:

Cholelithiasis and inflammatory biliary tract disease constitute a major health problem in western countries. Acute cholecystitis is the third major cause of emergency admission to a surgical ward and its incidence increases with increasing age. Acute cholecystitis is defined as acute inflammation of the gallbladder which is commonly caused by gallstones which are impacted in the cystic duct. The treatment of acute cholecystitis varies between different medical centers around the world. In some hospitals, mainly in the US, the most common treatment is early laparoscopic cholecystectomy within 72 hours from the onset of symptoms / admission. However, in the UK and many other centers in Europe the treatment of acute cholecystitis is conservative (NPO, IV fluids and antibiotics) and laparoscopic cholecystectomy is delayed. The reasons for delayed surgery differ between institutions and include the assumption of decreased complications, surgeon and OR availability and schedule, costs, and hospital policy.

A recent metanalysis proved similar safety and efficacy of early and delayed laparoscopic cholecystectomy. The conversion rate, length of operation and complication rate (overall complication rate, intra-abdominal collection, bile leak, and CBD injury) were also comparable.

At Hadassah-Hebrew University Medical Center, Mount Scopus patients with acute cholecystitis are treated conservatively followed by delayed laparoscopic cholecystectomy. Over the years this approach proved to carry relatively low rate of complications, mainly bile duct injuries <1%, without interruption to the busy OR schedule.

Regardless to the lack of evidence based guidelines for the treatment of acute cholecystitis the traditional triad of NPO, IV fluids and antibiotics was adopted at our institution vis-à-vis the higher complication and conversion rate for early cholecystectomy. The antibiotic treatment is associated with side effects, costs and most important unavoidable development of bacterial drug resistance. However, to date there are no randomized trials proving the superiority of either one of these methods.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients admitted through the emergency department that are diagnosed with acute cholecystits and meet the inclusion criteria will be given the opportunity to participate in the trial. Informed consent is required. Patients may withdraw from the study at any time without giving reasons and without jeopardizing further treatment.

Criteria

Inclusion Criteria:

Patients with the diagnosis of mild acute cholecystitis that meet the following:

  1. Sonographic (or CT) findings:

    1. cholelithiasis or sludge and
    2. wall thickening > 4 mm, and
    3. positive sonographic Murphy sign,
    4. distended gallbladder (optional)
    5. pericystic fluid (optional)
  2. Additional one of the following:

    1. epigastric or RUQ pain
    2. fever > 38.0
    3. WBC > 10,000

Exclusion criteria:

  1. Age - less than 18 or above 70
  2. Pregnant females
  3. Unconsentable patients
  4. NYHA > 3
  5. Use of steroids or immunosuppression
  6. Onset of typical abdominal pain for over than 72 hours
  7. Hemodynamic instability
  8. Fever > 39 or chills
  9. Palpable inflammatory RUQ mass
  10. Presence of peritonitis on physical examination
  11. WBC > 18,000
  12. Diastase > 200 (NL 20-100)
  13. Bilirubin > 85 (X5 the norm)
  14. Multi organ failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557453

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Haggi Mazeh, M.D. Hadassah Medical Organization
Study Director: Herbert R Freund, M.D. Hadassah Medical Organization
  More Information

Publications:
Responsible Party: Dr. Haggi Mazeh, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00557453     History of Changes
Other Study ID Numbers: cholecystitis-HMO-CTIL
Study First Received: November 11, 2007
Last Updated: July 12, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Cholecystitis
Acalculous Cholecystitis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on April 15, 2014