Prospective randomised trial of tubeless vs conventional percutaneous nephrolithotomy (PCNL)
| ISRCTN | ISRCTN67807054 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67807054 |
| Secondary identifying numbers | N0547147994 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 12/04/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Surgery
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 Sudhanshu Chitale
Scientific
Scientific
Department of Urology
Norfolk and Norwich University Hospital NHS Trust
Colney Lane
Norwich
NR4 7UY
United Kingdom
| Phone | +44 |
|---|---|
| sudhanshu.chitale@nnuh.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Is performing percutaneous renal surgery without leaving a tube drain in the kidney postoperatively as safe as with the placement of a postop drain? Our hypothesis is that, in selected cases, it is not only as safe but also associated with reduced postoperative morbidity and hospital stay. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Renal |
| Intervention | Comparison of two different approaches to keyhole surgery of the kidney with stone disease. Added 26 August 2008: trial stopped due to poor recruitment and lack of funding. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Postoperatve blood loss, postoperative incidence of infection and urinary leak (urinoma). |
| Secondary outcome measures | Analgesic requirement, hospital stay, readmission rates. |
| Overall study start date | 01/09/2003 |
| Completion date | 01/09/2005 |
| Reason abandoned (if study stopped) | Lack of funding & poor recruitment |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 115 in each arm = 230 |
| Key inclusion criteria | Adults with small-moderate size pelvicalyceal stones. |
| Key exclusion criteria | Patients with complete stones, solitary functioning kidney, renal insufficiency |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 01/09/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Urology
Norwich
NR4 7UY
United Kingdom
NR4 7UY
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
East Norfolk and Waveney Research Consortium - Norfolk and Norwich University Hospital/Norwich PCT (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 |
