Acute Cholecystitis Early Versus Delayed Cholecystectomy, A Multicenter Randomized Trial (ACDC Study, NCT00447304)

被引:332
作者
Gutt, Carsten N. [1 ]
Encke, Jens [2 ]
Koeninger, Joerg [1 ]
Harnoss, Julian-Camill [1 ]
Weigand, Kilian [2 ]
Kipfmueller, Karl [4 ]
Schunter, Oliver [5 ]
Goetze, Thorsten [6 ]
Golling, Markus T.
Menges, Markus
Klar, Ernst [7 ]
Feilhauer, Katharina [3 ]
Zoller, Wolfram G. [8 ]
Ridwelski, Karsten [9 ]
Ackmann, Sven [10 ]
Baron, Alexandra [11 ]
Schoen, Michael R. [12 ]
Seitz, Helmut K. [13 ]
Daniel, Dietmar [14 ]
Stremmel, Wolfgang [2 ]
Buechler, Markus W. [1 ,15 ]
机构
[1] Univ Heidelberg Hosp, Dept Surg, D-69120 Heidelberg, Germany
[2] Univ Heidelberg Hosp, Dept Internal Med 4, D-69120 Heidelberg, Germany
[3] Katharinen Hosp, Dept Surg, Stuttgart, Germany
[4] St Marien Hosp Muelheim, Dept Surg, Mulheim, Germany
[5] Bietigheim Hosp, Dept Surg, Bietigheim Bissingen, Germany
[6] Ketteler Hosp, Dept Surg, Offenbach, Germany
[7] Rostock Univ Hosp, Dept Surg, Rostock, Germany
[8] Katharinen Hosp, Dept Internal Med, Stuttgart, Germany
[9] Magdeburg Hosp, Dept Surg, Magdeburg, Germany
[10] Magdeburg Hosp, Dept Gastroenterol, Magdeburg, Germany
[11] Bad Cannstatt Hosp, Dept Surg, Stuttgart, Germany
[12] Karlsruhe Hosp, Karlsruhe, Germany
[13] Salem Hosp, Dept Internal Med, Heidelberg, Germany
[14] Res & Publ Relat, Burscheid, Germany
[15] Salem Hosp, Dept Surg, Heidelberg, Germany
关键词
cholecystitis; immediate vs delayed laparoscopic cholecystectomy; randomized trial; LAPAROSCOPIC-CHOLECYSTECTOMY; BILIARY-TRACT; COST-UTILITY; MOXIFLOXACIN; METAANALYSIS; MANAGEMENT; SURGERY; INFECTIONS; HOSPITALS; TIME;
D O I
10.1097/SLA.0b013e3182a1599b
中图分类号
R61 [外科手术学];
学科分类号
100210 [外科学];
摘要
Objective: Acute cholecystitis is a common disease, and laparoscopic surgery is the standard of care. Background: Optimal timing of surgery for acute cholecystitis remains controversial: either early surgery shortly after hospital admission or delayed elective surgery after a conservative treatment with antibiotics. Methods: The ACDC ("Acute Cholecystitis-early laparoscopic surgery versus antibiotic therapy and Delayed elective Cholecystectomy") study is a randomized, prospective, open-label, parallel group trial. Patients were randomly assigned to receive immediate surgery within 24 hours of hospital admission (group ILC) or initial antibiotic treatment, followed by delayed laparoscopic cholecystectomy at days 7 to 45 (group DLC). For infection, all patients were treated with moxifloxacin for at least 48 hours. Primary endpoint was occurrence of predefined relevant morbidity within 75 days. Secondary endpoints were as follows: (1) 75-day morbidity using a scoring system; (2) conversion rate; (3) change of antibiotic therapy; (4) mortality; (5) costs; and (6) length of hospital stay. Results: Morbidity rate was significantly lower in group ILC (304 patients) than in group DLC (314 patients): 11.8% versus 34.4%. Conversion rate to open surgery and mortality did not differ significantly between groups. Mean length of hospital stay (5.4 days vs 10.0 days; P < 0.001) and total hospital costs ((sic)2919 vs (sic)4262; P < 0.001) were significantly lower in group ILC. Conclusions: In this large, randomized trial, laparoscopic cholecystectomy within 24 hours of hospital admission was shown to be superior to the conservative approach concerning morbidity and costs. Therefore, we believe that immediate laparoscopic cholecystectomy should become therapy of choice for acute cholecystitis in operable patients. (NCT00447304)
引用
收藏
页码:385 / 393
页数:9
相关论文
共 26 条
[1]
Population-Based Analysis of 4113 Patients With Acute Cholecystitis Defining the Optimal Time-Point for Laparoscopic Cholecystectomy [J].
Banz, Vanessa ;
Gsponer, Thomas ;
Candinas, Daniel ;
Gueller, Ulrich .
ANNALS OF SURGERY, 2011, 254 (06) :964-970
[2]
10 years' experience with the pneumococcal quinolone moxifloxacin [J].
Burkhardt, Olaf ;
Welte, Tobias .
EXPERT REVIEW OF ANTI-INFECTIVE THERAPY, 2009, 7 (06) :645-668
[3]
Management of acute cholecystitis in UK hospitals: time for a change [J].
Cameron, IC ;
Chadwick, C ;
Phillips, J ;
Johnson, AG .
POSTGRADUATE MEDICAL JOURNAL, 2004, 80 (943) :292-294
[4]
Cheruvu CVN, 2002, ANN ROY COLL SURG, V84, P20
[5]
In vitro activities of moxifloxacin against 900 aerobic and anaerobic surgical isolates from patients with intra-abdominal and diabetic foot infections [J].
Edmiston, CE ;
Krepel, CJ ;
Seabrook, GR ;
Somberg, LR ;
Nakeeb, A ;
Cambria, RA ;
Towne, JB .
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 2004, 48 (03) :1012-1016
[6]
Clinical update: early surgery for acute cholecystitis [J].
Germanos, Stylianos ;
Gourgiotis, Stavros ;
Kocher, Hemant M. .
LANCET, 2007, 369 (9575) :1774-1776
[7]
Meta-analysis of randomized controlled trials on the safety and effectiveness of early versus delayed laparoscopic cholecystectomy for acute cholecystitis [J].
Gurusamy, K. ;
Samraj, K. ;
Gluud, C. ;
Wilson, E. ;
Davidson, B. R. .
BRITISH JOURNAL OF SURGERY, 2010, 97 (02) :141-150
[8]
Early versus delayed laparoscopic cholecystectomy for acute cholecystitis [J].
Gurusamy, K. S. ;
Samraj, K. .
COCHRANE DATABASE OF SYSTEMATIC REVIEWS, 2006, (04)
[9]
Management of acute cholecystitis in the laparoscopic era: Results of a prospective, randomized clinical trial [J].
Johansson, M ;
Thune, A ;
Blomqvist, A ;
Nelvin, L ;
Lundell, L .
JOURNAL OF GASTROINTESTINAL SURGERY, 2003, 7 (05) :642-645
[10]
Early vs delayed laparoscopic cholecystectomy for acute cholecystitis - A prospective randomized trial [J].
Kolla, SB ;
Aggarwal, S ;
Kumar, A ;
Kumar, R ;
Chumber, S ;
Parshad, R ;
Seenu, V .
SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES, 2004, 18 (09) :1323-1327