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

July 20, 2012 updated by: Heidelberg University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

644

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • University Hospital Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
morbidity at the test-of-cure visit

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 13, 2007

First Submitted That Met QC Criteria

March 13, 2007

First Posted (Estimate)

March 14, 2007

Study Record Updates

Last Update Posted (Estimate)

July 23, 2012

Last Update Submitted That Met QC Criteria

July 20, 2012

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-002056-14
  • AC-DC-01/Version 02/6.04.06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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