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

NCT00557453 | Completed DMC

• 1 other identifier: cholecystitis-HMO-CTIL
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Cholecystitits

Study Arms (2)

A

Antibiotic treatment

Drug: Antibiotic treatment

B

Non antibiotic treatment

Drug: No antibiotics

Interventions

Antibiotic treatment DRUG

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.

A

No antibiotics DRUG

Allowed medications for both groups will include PPI / H2 blockers, home medication, SC insulin for diabetes, and SC clexane if indicated.

B

Eligibility Criteria

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

You may qualify if:

• Patients with the diagnosis of mild acute cholecystitis that meet the following:
• Sonographic (or CT) findings:
• cholelithiasis or sludge and
• wall thickening \> 4 mm, and
• positive sonographic Murphy sign,
• distended gallbladder (optional)
• pericystic fluid (optional)
• Additional one of the following:
• epigastric or RUQ pain
• fever \> 38.0
• WBC \> 10,000

You may not qualify if:

• Age - less than 18 or above 70
• Pregnant females
• Unconsentable patients
• NYHA \> 3
• Use of steroids or immunosuppression
• Onset of typical abdominal pain for over than 72 hours
• Hemodynamic instability
• Fever \> 39 or chills
• Palpable inflammatory RUQ mass
• Presence of peritonitis on physical examination
• WBC \> 18,000
• Diastase \> 200 (NL 20-100)
• Bilirubin \> 85 (X5 the norm)
• Multi organ failure

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Related Publications (1)

• Yoshida M, Takada T, Kawarada Y, Tanaka A, Nimura Y, Gomi H, Hirota M, Miura F, Wada K, Mayumi T, Solomkin JS, Strasberg S, Pitt HA, Belghiti J, de Santibanes E, Fan ST, Chen MF, Belli G, Hilvano SC, Kim SW, Ker CG. Antimicrobial therapy for acute cholecystitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg. 2007;14(1):83-90. doi: 10.1007/s00534-006-1160-y. Epub 2007 Jan 30.

  PMID: 17252301 BACKGROUND

Study Officials

• Haggi Mazeh, M.D.

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

• Herbert R Freund, M.D.

  Hadassah Medical Organization

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 11, 2007
• First Posted: November 14, 2007
• Study Start: April 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 13, 2010

Record last verified: 2010-04

Locations

IL (1)