Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT00447304
Status:
COMPLETED
Last Update Posted:
2012-07-23
First Post:
2007-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041881', 'term': 'Cholecystitis, Acute'}, {'id': 'D059413', 'term': 'Intraabdominal Infections'}], 'ancestors': [{'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077266', 'term': 'Moxifloxacin'}, {'id': 'D002763', 'term': 'Cholecystectomy'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 644}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-20', 'studyFirstSubmitDate': '2007-03-13', 'studyFirstSubmitQcDate': '2007-03-13', 'lastUpdatePostDateStruct': {'date': '2012-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morbidity at the test-of-cure visit'}], 'secondaryOutcomes': [{'measure': 'Morbidity over 75 days using the score system showed in table 1'}, {'measure': 'Morbidity 3 days after cholecystectomy (early or elective)'}, {'measure': 'Necessity rate of conversion from laparoscopic to open surgery'}, {'measure': 'Change of antibiotic due to non-response or non-toleration of moxifloxacin'}, {'measure': 'Mortality at day 75'}, {'measure': 'Cost-efficiency (comparing both trial branches)'}, {'measure': 'Hospital time'}, {'measure': 'Safety and tolerability of Moxifloxacin'}, {'measure': 'In-hospital time after cholecystectomy (days)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute cholecystitis', 'cholecystectomy', 'antibiotic treatment', 'moxifloxacin', 'intraabdominal infection', 'morbidity and mortality of patients with acute cholecystitis, early surgery versus conservative therapy'], 'conditions': ['Acute Cholecystitis']}, 'referencesModule': {'references': [{'pmid': '24022431', 'type': 'DERIVED', '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.'}, {'pmid': '17916243', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients of age \\> 18 years\n* Patients with acute cholecystitis based on three of the following signs\n\n * abdominal pain in the upper right quadrant\n * Murphy's sign\n * leucocytosis \\> 10 /ml\n * rectal temperature \\> 38 °C or \\< 36.5 °C plus\n * cholecystolithiasis (stones / sludge) or sonographic signs of cholecystitis (thickening and triple layer formation of the gall bladder wall)\n* Immediate antibiotic therapy (400 mg Moxifloxacin i.v. once a day)\n* Laparoscopic cholecystectomy possible within 24 hours after presentation of the patient\n* Informed consent\n\nExclusion Criteria:\n\n* ASA IV and V (table 2)\n* Septic shock\n* Perforation or abscess of the gall bladder\n* Impossibility of laparoscopic surgery (further surgery, surgeon, …)\n* Additional need of antibiotics due to secondary disease\n* Known intolerability of Moxifloxacin\n* Known or possible pregnancy, breast feeding\n* Life-threatening diseases (life-expectancy \\< 48 hours)\n* End-stage liver disease (Child-Pugh C)\n* Psychiatric or severe neurologic disease\n* Relevant bradycardia or other symptomatic arrhythmias\n* Significant cardiac disease\n* Known long QT-disorders\n* Electrolyte disorders, especially hypocalcemia\n* Known intolerability of chinolones\n* Earlier participation in this trial"}, 'identificationModule': {'nctId': 'NCT00447304', 'acronym': 'ACDC', 'briefTitle': 'Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy = ACDC-study', 'orgStudyIdInfo': {'id': '2006-002056-14'}, 'secondaryIdInfos': [{'id': 'AC-DC-01/Version 02/6.04.06'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'moxifloxacin', 'type': 'DRUG'}, {'name': 'cholecystectomy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'University Hospital Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Markus W Buechler, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Heidelberg, Department of Surgery, Heidelberg, Germany'}, {'name': 'Wolfgang Stremmel, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Heidelberg, Department of Gastroenterology, Heidelberg, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}]}}}