Early laparoscopic cholecystectomy versus conventional management for newly diagnosed gallbladder disease
| ISRCTN | ISRCTN81663421 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81663421 |
| Secondary identifying numbers | N0192151057 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 08/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Mr D N Lobo
Scientific
Scientific
Division of GI Surgery
E Floor West Block
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)115 970 9245 |
|---|---|
| dileep.lobo@nottingham.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 hypothesis | 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 |
| Condition | Gallbladder diseases |
| Intervention | 1. Laparoscopic cholecystectomy 2. Analgesia intravenous fluids and antibiotics |
| Intervention type | Other |
| Primary outcome measure | To see whether early management has a bearing on gallstone related morbidity and mortality. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2004 |
| Overall study end date | 28/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 138 (69 each in the early and conventional groups) |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/09/2004 |
| Recruitment end date | 28/02/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Division of GI Surgery
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Queens Medical Centre University Hospital (UK) - NHS R&D Support Funding
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | cost utility results | 01/09/2009 | Yes | No |
