Early laparoscopic cholecystectomy versus conventional management for newly diagnosed gallbladder disease

ISRCTN	ISRCTN81663421
DOI	https://doi.org/10.1186/ISRCTN81663421
Protocol serial number	N0192151057
Sponsor	Department of Health
Funder	Queens Medical Centre University Hospital (UK) - NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr D N Lobo
Scientific

Division of GI Surgery
E Floor West Block
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

Phone	+44 (0)115 970 9245
Email	dileep.lobo@nottingham.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled trial of early laparoscopic cholecystectomy versus conventional management for newly diagnosed gallbladder disease: a cost minimisation and outcome study
Study objectives	Comparing the direct hospital-based and the societal costs of early and conventional management for newly diagnosed gallbladder disease.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Gallbladder diseases
Intervention	1. Laparoscopic cholecystectomy 2. Analgesia intravenous fluids and antibiotics
Intervention type	Other
Primary outcome measure(s)	To see whether early management has a bearing on gallstone related morbidity and mortality.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	28/02/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	138
Key inclusion criteria	1. Male and females 2. Aged 18 - 80 years 3. Residing in Nottingham area 4. Presenting with primary diagnosis of bilary colic or acute cholecystitis
Key exclusion criteria	1. Patients diagnosed with acute severe gallstone pancreatis or gallstone-related ascending cholangitis (Jaundice temperature greater than 39°C and rigors) 2. Patients less than 18 or more than 80 years 3. Patients who have medical co-morbidity preventing either laparoscopic cholecystectomy or potential inclusion in either treatment arm
Date of first enrolment	01/09/2004
Date of final enrolment	28/02/2007

Division of GI Surgery

Nottingham
NG7 2UH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	cost utility results	01/09/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes