Clinical trial NCT00447304: Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy
Official title: Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy = ACDC-study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Cholecystitis
Keywords: acute cholecystitis
cholecystectomy
antibiotic treatment
moxifloxacin
intraabdominal infection
morbidity and mortality of patients with acute cholecystitis, early surgery versus conservative therapy
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2007-03-14
Enrollment: 644
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: morbidity at the test-of-cure visit
Secondary outcomes:
measure: Morbidity over 75 days using the score system showed in table 1
measure: Morbidity 3 days after cholecystectomy (early or elective)
measure: Necessity rate of conversion from laparoscopic to open surgery
measure: Change of antibiotic due to non-response or non-toleration of moxifloxacin
measure: Mortality at day 75
measure: Cost-efficiency (comparing both trial branches)
measure: Hospital time
measure: Safety and tolerability of Moxifloxacin
measure: In-hospital time after cholecystectomy (days)
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
Study officials:
affiliation: University Hospital Heidelberg, Department of Surgery, Heidelberg, Germany
name: Markus W Buechler, Prof.
role: STUDY_DIRECTOR
affiliation: University Hospital Heidelberg, Department of Gastroenterology, Heidelberg, Germany
name: Wolfgang Stremmel, Prof
role: STUDY_DIRECTOR
References:
citation: Gutt CN, Encke J, Koninger J, Harnoss JC, Weigand K, Kipfmuller K, Schunter O, Gotze T, Golling MT, Menges M, Klar E, Feilhauer K, Zoller WG, Ridwelski K, Ackmann S, Baron A, Schon MR, Seitz HK, Daniel D, Stremmel W, Buchler MW. Acute cholecystitis: early versus delayed cholecystectomy, a multicenter randomized trial (ACDC study, NCT00447304). Ann Surg. 2013 Sep;258(3):385-93. doi: 10.1097/SLA.0b013e3182a1599b.
citation: Weigand K, Koninger J, Encke J, Buchler MW, Stremmel W, Gutt CN. Acute cholecystitis - early laparoskopic surgery versus antibiotic therapy and delayed elective cholecystectomy: ACDC-study. Trials. 2007 Oct 4;8:29. doi: 10.1186/1745-6215-8-29.