Acute cholecystitis in high risk patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy; a randomized controlled, open, parallel, superiority, multicenter trial
Completed
- Conditions
- cholecystitisinflamed gallbladder1001762810019818
- Registration Number
- NL-OMON40048
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 284
Inclusion Criteria
APACHE-II score >= 7 AND <= 14
Acute calculous cholecystitis
Written informed consent
Exclusion Criteria
Onset of symptoms >=7 days before first presentation
Already admitted to ICU
Pregnancy
<18 Years of age
Acalculous cholecystitis
Decompensated liver cirrhosis
Mental illness prohibiting informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Combined endpoint including all major complications, need for re-intervention<br /><br>and mortality. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Individual components of composite endpoint, Minor complications, Difficulty of<br /><br>cholecystectomy, total length of hospital stay, emergency room visits, cost<br /><br>efficiency</p><br>