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

• ClinicalTrials.gov Identifier: NCT00447304
• Recruitment Status: Completed
• First Posted: March 14, 2007
• Last Update Posted: July 23, 2012
• Sponsor: Heidelberg University
• Collaborator: Bayer
• Information provided by: Heidelberg University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Cholecystitis	Drug: moxifloxacin; Procedure: cholecystectomy	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 644 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy = ACDC-study
• Study Start Date: October 2006
• Actual Primary Completion Date: November 2010
• Actual Study Completion Date: December 2010

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. morbidity at the test-of-cure visit

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Germany

University Hospital Heidelberg

Heidelberg, Germany, 69120

Sponsors and Collaborators

Heidelberg University

Bayer

Investigators

• Study Director: Markus W Buechler, Prof.; University Hospital Heidelberg, Department of Surgery, Heidelberg, Germany
• Study Director: Wolfgang Stremmel, Prof; University Hospital Heidelberg, Department of Gastroenterology, Heidelberg, Germany

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• ClinicalTrials.gov Identifier: NCT00447304
• Other Study ID Numbers: 2006-002056-14; AC-DC-01/Version 02/6.04.06
• First Posted: March 14, 2007
• Last Update Posted: July 23, 2012
• Last Verified: March 2007

Keywords provided by Heidelberg University:

acute cholecystitis; cholecystectomy; antibiotic treatment; moxifloxacin; intraabdominal infection; morbidity and mortality of patients with acute cholecystitis, early surgery versus conservative therapy

Additional relevant MeSH terms:

Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Moxifloxacin; Anti-Bacterial Agents; Anti-Infective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents