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

Brief Title

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

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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

morbidity at the test-of-cure visit

Secondary Outcome

 Morbidity over 75 days using the score system showed in table 1

Condition

Acute Cholecystitis

Intervention

moxifloxacin

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

October 2006

Completion Date

December 2010

Primary Completion Date

November 2010

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Markus W Buechler, Prof., ,

Location Countries

Germany

Location Countries

Germany

Administrative Informations

NCT ID

NCT00447304

Organization ID

2006-002056-14

Secondary IDs

AC-DC-01/Version 02/6.04.06

Study Sponsor

Heidelberg University

Collaborators

 Bayer

Study Sponsor

Markus W Buechler, Prof., Study Director, University Hospital Heidelberg, Department of Surgery, Heidelberg, Germany

Verification Date

March 2007