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

NCT00447304 | Completed Phase 3 DMC

• 2 other identifiers: 2006-002056-14AC-DC-01/Version 02/6.04.06
• Study Type: interventional
• Target: 644
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Cholecystitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• morbidity at the test-of-cure visit

Secondary Outcomes (9)

• 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

Interventions

moxifloxacin DRUG

cholecystectomy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead
• Bayer: collaborator

Study Sites (1)

University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (2)

• 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.

  PMID: 24022431 DERIVED

• 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.

  PMID: 17916243 DERIVED

MeSH Terms

Conditions

Cholecystitis, Acute; Intraabdominal Infections

Interventions

Moxifloxacin; Cholecystectomy

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Infections

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 13, 2007
• First Posted: March 14, 2007
• Study Start: October 1, 2006
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 23, 2012

Record last verified: 2007-03

Locations

DE (1)