Laparoscopic cholecystectomy versus radiological drainage of the gallbladder in acute cholecystitis.

Laparoscopic cholecystectomy versus percutaneous cholecystostomy in acute calculous cholecystitis in high risk patients.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24221

Enrollment

302

Registered

2010-12-27

Start date

2011-02-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Acute calculous cholecystitis

Interventions

1. Laparoscopic Cholecystectomy

2. Percutaneous Cholecystostomy.

Eligibility

Inclusion criteria

Inclusion criteria: 1. APACHE-II score greater than or equal to 7 AND smaller than or equall to 14; 2. Acute calculous cholecystitis, defined according to Tokyo Guidelines; 3. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. < 18 years of age; 2. Onset of symptoms lesser than or equal to 7 days before first presentation; 3. Already admitted to ICU; 4. Pregnancy; 5. APACHE-II score smaller than or equal to 6 OR greater than or equal to 15; 6. Acalculous cholecystitis; 7. Decompensated liver cirrhosis; 8. Mental illness prohibiting informed consent.

Design outcomes

Primary

Measure	Time frame
1. Mortality; 2. All procedure related major morbidity (Infectious complications, cardio-pulmonary complications, need for re-intervention, recurrent biliary disease).	—

Secondary

Measure	Time frame
1. All individual components of primary endpoint; 2. Length of hospital admission; 3. Time to full recovery; 4. Cost-effectiveness analysis.	—

Contacts

Public ContactD. Boerma

St Antonius Hospital, Department of Surgery, P.O. Box 2500

djamilaboerma@hotmail.com

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)