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| ID | Type | Description | Link |
|---|---|---|---|
| AC-DC-01/Version 02/6.04.06 |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| moxifloxacin | Drug | |||
| cholecystectomy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| morbidity at the test-of-cure visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Patients of age > 18 years
Patients with acute cholecystitis based on three of the following signs
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:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Heidelberg | Heidelberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24022431 | Derived | 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. | |
| 17916243 |
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| ID | Term |
|---|---|
| D041881 | Cholecystitis, Acute |
| D059413 | Intraabdominal Infections |
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| D002763 | Cholecystectomy |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| 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) |
| 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. |
| D007239 |
| Infections |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |