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

Phase 3

Completed

• Conditions: Acute Cholecystitis

• Registration Number: NCT00447304
• Lead Sponsor: Heidelberg University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Status Verified: 2007-03
• Study First Submitted: 2007-03-13
• Study First Submitted QC: 2007-03-13
• Study First Posted: 2007-03-14
• Primary Completion: 2010-11
• Study Completion: 2010-12
• Last Update Submitted: 2012-07-20
• Last Update Posted: 2012-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 644

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
morbidity at the test-of-cure visit

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Heidelberg; 🇩🇪 Heidelberg, Germany