The timings of cholecystectomy in acute pancreatitis
ISRCTN | ISRCTN42476855 |
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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
Scientific
Countess of Chester NHS Trust
Liverpool Road
Chester
CH3 1UL
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | The timings of cholecystectomy in acute pancreatitis: a randomised controlled trial |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Pancreatitis |
Intervention | Patients with acute gallstone pancreatitis will be randomised to undergo early (2 weeks) or late (6 weeks) cholecystectomy. |
Intervention type | Procedure/Surgery |
Primary outcome measure | 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 study start date | 01/04/2001 |
Completion date | 01/04/2003 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | Approximately 100 participants |
Key inclusion criteria | All patients admitted with acute pancreatitis secondary to gallstones will be admitted into study. |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/04/2001 |
Date of final enrolment | 01/04/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Countess of Chester NHS Trust
Chester
CH3 1UL
United Kingdom
CH3 1UL
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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Funders
Funder type
Government
Countess of Chester Hospital NHS Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |