Acute cholecystitis in high risk patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy; a randomized controlled, open, parallel, superiority, multicenter trial

Acute cholecystitis in high risk patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy; a randomized controlled, open, parallel, superiority, multicenter trial - CHOCOLATE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40048

Enrollment

284

Registered

2011-01-15

Start date

2011-02-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cholecystitis inflamed gallbladder

Interventions

The study has two treatment arms

arm one will be treated with laparoscopic cholecystectomy, arm two with percutaneous cholecystostomy.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: APACHE-II score >= 7 AND

Exclusion criteria

Exclusion criteria: Onset of symptoms >=7 days before first presentation Already admitted to ICU Pregnancy

Design outcomes

Primary

Measure	Time frame
Combined endpoint including all major complications, need for re-intervention and mortality.	—

Secondary

Measure	Time frame
Individual components of composite endpoint, Minor complications, Difficulty of cholecystectomy, total length of hospital stay, emergency room visits, cost efficiency	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)