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
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
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
NCT ID
NCT00447304
First Posted
March 13, 2007
Last Updated
July 20, 2012
Sponsor
Heidelberg University
Collaborators
Bayer
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
Learn more about this trial
Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy
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