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

NCT00447304 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 644

Last updated 2012-07-23

No results posted yet for this study

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

Interventions

DRUG

moxifloxacin

PROCEDURE

cholecystectomy

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Markus W Buechler, Prof. · University Hospital Heidelberg, Department of Surgery, Heidelberg, Germany

  • Wolfgang Stremmel, Prof · University Hospital Heidelberg, Department of Gastroenterology, Heidelberg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2010-11-30
Completion
2010-12-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00447304 on ClinicalTrials.gov