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

Primary Purpose

Acute Cholecystitis

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
moxifloxacin
cholecystectomy
Sponsored by
Heidelberg University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Cholecystitis focused on measuring acute cholecystitis, cholecystectomy, antibiotic treatment, moxifloxacin, intraabdominal infection, morbidity and mortality of patients with acute cholecystitis, early surgery versus conservative therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Heidelberg

Outcomes

Primary Outcome Measures

morbidity at the test-of-cure visit

Secondary Outcome Measures

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)

Full Information

First Posted
March 13, 2007
Last Updated
July 20, 2012
Sponsor
Heidelberg University
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00447304
Brief Title
Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy
Acronym
ACDC
Official Title
Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy = ACDC-study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Heidelberg University
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholecystitis
Keywords
acute cholecystitis, cholecystectomy, antibiotic treatment, moxifloxacin, intraabdominal infection, morbidity and mortality of patients with acute cholecystitis, early surgery versus conservative therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
644 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
moxifloxacin
Intervention Type
Procedure
Intervention Name(s)
cholecystectomy
Primary Outcome Measure Information:
Title
morbidity at the test-of-cure visit
Secondary Outcome Measure Information:
Title
Morbidity over 75 days using the score system showed in table 1
Title
Morbidity 3 days after cholecystectomy (early or elective)
Title
Necessity rate of conversion from laparoscopic to open surgery
Title
Change of antibiotic due to non-response or non-toleration of moxifloxacin
Title
Mortality at day 75
Title
Cost-efficiency (comparing both trial branches)
Title
Hospital time
Title
Safety and tolerability of Moxifloxacin
Title
In-hospital time after cholecystectomy (days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus W Buechler, Prof.
Organizational Affiliation
University Hospital Heidelberg, Department of Surgery, Heidelberg, Germany
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wolfgang Stremmel, Prof
Organizational Affiliation
University Hospital Heidelberg, Department of Gastroenterology, Heidelberg, Germany
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24022431
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.
Results Reference
derived
PubMed Identifier
17916243
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.
Results Reference
derived

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

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