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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

644 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Cholecystitis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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moxifloxacin

Intervention Type DRUG

cholecystectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Markus W Buechler, Prof.

Role: STUDY_DIRECTOR

University Hospital Heidelberg, Department of Surgery, Heidelberg, Germany

Wolfgang Stremmel, Prof

Role: STUDY_DIRECTOR

University Hospital Heidelberg, Department of Gastroenterology, Heidelberg, Germany

Locations

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University Hospital Heidelberg

Heidelberg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED

PMID: 24022431 (View on PubMed)

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.