To compare the outcome of early laparoscopic cholecystectomy (
ID
Source
Brief title
Condition
- Exocrine pancreas conditions
- Bile duct disorders
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Acute re-admission for biliary events (recurrent biliary pancreatitis, acute
cholecystitis,
choledocholithiasis mandating ERCP or biliary colics).
Secondary outcome
- patient satisfaction, medical and indirect costs in terms of volumes of
resource utilization in relation to outcome (cost-effectiveness analysis)
- individual components of the primary endpoint: number of biliary colics after
randomization, length
of stay, difficulty of operation (VAS), duration and complications of
cholecystectomy, conversion rate of laparoscopic to open
cholecystectomy, length of stay, mortality.
Background summary
After biliary pancreatitis, cholecystectomy should be performed in order to
reduce recurrent biliary disease (pancreatitis,
cholecystitis). Current guidelines advocate cholecystectomy to be performed
within 2-4 weeks after discharge. During that
period, however, the patient is at risk for recurrent biliary disease. Based on
a pilot study and a systematic review we expect
that early laparoscopic cholecystectomy (<72 hrs after randomization), as
compared to interval cholecystectomy
(25-30 days after randomization), reduces recurrent biliary disease after mild
biliary pancreatitis.
Study objective
To compare the outcome of early laparoscopic cholecystectomy (<72 hrs after
randomization) with interval laparoscopic cholecystectomy (25-30 days after
randomization) after mild biliary pancreatitis.
Study design
A randomized controlled parallel-group superiority trial in 18 Dutch hospitals.
Intervention
A) Laparoscopic cholecystectomy within 72h after randomization, versus
B) Laparoscopic cholecystectomy 25-30 days after randomization.
Patients are randomized at that time the treating physician feels the patient
can be discharged within 1-2 days and all signs of
acute disease have resolved.
Study burden and risks
Research has shown that there is probably not a potential risk of an early
laparoscopic cholecystectomy compared to an interval laparoscopic
cholecystectomy. The burden is minimal, average 1 hour in total (forms,
telephone follow-up and questionnaire).
However the minimalisation of recurrent biliary disease due to an early
intervention is a clear benefit for patients.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
- age 18 years or older
- mild (non-severe) biliary pancreatitis, without sterile pancreatic necrosis and/or peripancreatic collections.
- first episode of pancreatitis
- written and oral informed consent
Exclusion criteria
- patients <18 years
- patients >75 years with ASA III
- ASA IV and V patients
- patients with history of alcohol abuse or chronic pancreatitis
- mild pancreatitis with sterile pancreatic necrosis and/or peripancreatic collections
- severe pancreatitis: persistent (>48hrs) organ failure or necrotizing pancreatitis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32395.091.10 |