Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy

Acute Cholecystitis Clinical Trial

— ACDC  

Official title:

Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy = ACDC-study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447304
• Other study ID #: 2006-002056-14
• Secondary ID: AC-DC-01/Version
• Status: Completed
• Phase: Phase 3
• First received: March 13, 2007
• Last updated: July 20, 2012
• Start date: October 2006
• Est. completion date: December 2010

Study information

• Verified date: March 2007
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Acute cholecystitis is frequent in the elderly, or in patients with gall stones. Most cases of severe or recurrent cholecystitis need surgery as final therapy. Today, the performed procedure in most cases for cholecystectomy in the western world is laparoscopic cholecystectomy. Only in some cases an open surgery has to be performed. Unclear is, what time point is best, concerning outcome and morbidity of the patient, immediate surgery or initial conservative therapy using antibiotics and symptomatic therapy with cholecystectomy later on. Today the performed procedure is mainly chosen by the fact, what doctor sees the patient first, surgeon or gastroenterologist. This study is performed to evaluate if one therapy is superior.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 644
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients of age > 18 years

• Patients with acute cholecystitis based on three of the following signs

• abdominal pain in the upper right quadrant

• Murphy's sign

• leucocytosis > 10 /ml

• rectal temperature > 38 °C or < 36.5 °C plus

• cholecystolithiasis (stones / sludge) or sonographic signs of cholecystitis (thickening and triple layer formation of the gall bladder wall)

• Immediate antibiotic therapy (400 mg Moxifloxacin i.v. once a day)

• Laparoscopic cholecystectomy possible within 24 hours after presentation of the patient

• Informed consent

Exclusion Criteria:

• ASA IV and V (table 2)

• Septic shock

• Perforation or abscess of the gall bladder

• Impossibility of laparoscopic surgery (further surgery, surgeon, …)

• Additional need of antibiotics due to secondary disease

• Known intolerability of Moxifloxacin

• Known or possible pregnancy, breast feeding

• Life-threatening diseases (life-expectancy < 48 hours)

• End-stage liver disease (Child-Pugh C)

• Psychiatric or severe neurologic disease

• Relevant bradycardia or other symptomatic arrhythmias

• Significant cardiac disease

• Known long QT-disorders

• Electrolyte disorders, especially hypocalcemia

• Known intolerability of chinolones

• Earlier participation in this trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute

Intervention

Drug:
• moxifloxacin

Procedure:
• cholecystectomy

Locations

Country	Name	City	State
Germany	University Hospital Heidelberg	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
Heidelberg University	Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morbidity at the test-of-cure visit
Secondary	Morbidity over 75 days using the score system showed in table 1
Secondary	Morbidity 3 days after cholecystectomy (early or elective)
Secondary	Necessity rate of conversion from laparoscopic to open surgery
Secondary	Change of antibiotic due to non-response or non-toleration of moxifloxacin
Secondary	Mortality at day 75
Secondary	Cost-efficiency (comparing both trial branches)
Secondary	Hospital time
Secondary	Safety and tolerability of Moxifloxacin
Secondary	In-hospital time after cholecystectomy (days)