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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular

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