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Pancreatitis of biliary origin, Optimal timiNg of CHOlecystectomy (PONCHO)

Pancreatitis of biliary origin, Optimal timiNg of CHOlecystectomy (PONCHO) - PONCHO trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36818
Enrollment
266
Registered
2010-07-22
Start date
2010-11-01
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

biliary pancreatitis

Interventions

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 feel

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - 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 outcomes

Primary

MeasureTime frame
Acute re-admission for biliary events (recurrent biliary pancreatitis, acute cholecystitis, choledocholithiasis mandating ERCP or biliary colics).

Secondary

MeasureTime frame
- 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)