Prospective randomised trial of tubeless vs conventional percutaneous nephrolithotomy (PCNL)
| ISRCTN | ISRCTN67807054 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67807054 |
| Protocol serial number | N0547147994 |
| Sponsor | Department of Health |
| Funder | East Norfolk and Waveney Research Consortium - Norfolk and Norwich University Hospital/Norwich PCT (UK), NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Postoperatve blood loss, postoperative incidence of infection and urinary leak (urinoma). |
| Key secondary outcome measure(s) |
Analgesic requirement, hospital stay, readmission rates. |
| 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 sample size at registration | 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
- United Kingdom
- England
Study participating centre
Department of Urology
Norwich
NR4 7UY
United Kingdom
NR4 7UY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
