Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0072101043
Study information
Scientific title
The timings of cholecystectomy in acute pancreatitis: a randomised controlled trial
Acronym
Study hypothesis
1. 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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pancreatitis
Intervention
Patients with acute gallstone pancreatitis will be randomised to undergo early (2 weeks) or late (6 weeks) cholecystectomy.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
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
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2001
Overall trial end date
01/04/2003
Reason abandoned
Eligibility
Participant inclusion criteria
All patients admitted with acute pancreatitis secondary to gallstones will be admitted into study.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Approximately 100 participants
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/2001
Recruitment end date
01/04/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Countess of Chester NHS Trust
Chester
CH3 1UL
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Countess of Chester Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary