The timings of cholecystectomy in acute pancreatitis

ISRCTN ISRCTN42476855
DOI https://doi.org/10.1186/ISRCTN42476855
Secondary identifying numbers N0072101043
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
22/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Paul Edwards
Scientific

Countess of Chester NHS Trust
Liverpool Road
Chester
CH3 1UL
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe timings of cholecystectomy in acute pancreatitis: a randomised controlled trial
Study objectives1. Does a cholecystectomy within 2 weeks of an attack of acute pancreatitis prevent recurrent pancreatitis events?
2. Does a cholecystectomy within 2 weeks compared with delayed surgery (6 weeks) affect complications and hospital stay duration?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPancreatitis
InterventionPatients with acute gallstone pancreatitis will be randomised to undergo early (2 weeks) or late (6 weeks) cholecystectomy.
Intervention typeProcedure/Surgery
Primary outcome measure1. Risk of recurrent pancreatitis in delayed surgery groups
2. Operative complication rate
3. Local complications in delayed surgery group such as pseudocyst
4. Total length of time in hospital - mortality rates
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/2001
Completion date01/04/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsApproximately 100 participants
Key inclusion criteriaAll patients admitted with acute pancreatitis secondary to gallstones will be admitted into study.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/04/2001
Date of final enrolment01/04/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Countess of Chester NHS Trust
Chester
CH3 1UL
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Countess of Chester Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan