The timings of cholecystectomy in acute pancreatitis

ISRCTN	ISRCTN42476855
DOI	https://doi.org/10.1186/ISRCTN42476855
Secondary identifying numbers	N0072101043

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

Mr Paul Edwards
Scientific

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

Study design	Randomised controlled trial
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

Participant type(s)	Patient
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

Countess of Chester NHS Trust

Chester
CH3 1UL
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Government

Countess of Chester Hospital NHS Trust (UK)

No information available

Intention to publish date
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