Clinical Trial: Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Acute Cholecystitis - Early Laparoscopic Surgery Versus Antibiotic Therapy and Delayed Elective Cholecystectomy = ACDC-study
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.
Detailed Summary:
Sponsor: Heidelberg University
Current Primary Outcome: morbidity at the test-of-cure visit
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
- Cost-efficiency (comparing both trial branches)
- Hospital time
- Safety and tolerability of Moxifloxacin
- In-hospital time after cholecystectomy (days)
Original Secondary Outcome: Same as current
Information By: Heidelberg University
Dates:
Date Received: March 13, 2007
Date Started: October 2006
Date Completion:
Last Updated: July 20, 2012
Last Verified: March 2007
