Acute Cholecystitits Clinical Trial
Official title:
The Role of Antibiotic Treatment in Patients With Acute Mild Cholecystitis - A Prospective Randomized Controlled Trial
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | April 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Israel | Hadassah Medical Organization | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization |
Israel,
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. Epub 2007 Jan 30. — View Citation