ISRCTN ISRCTN42476855
DOI https://doi.org/10.1186/ISRCTN42476855
Protocol serial number N0072101043
Sponsor Department of Health (UK)
Funder Countess of Chester Hospital NHS Trust (UK)
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

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
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 measure(s)

1. 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

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/04/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration100
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

  • United Kingdom
  • England

Study participating centre

Countess of Chester NHS Trust
Chester
CH3 1UL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan