A randomised clinical trial to evaluate the effect of reducing the shock wave frequency during shock wave lithotripsy for renal calculi
| ISRCTN | ISRCTN08124462 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08124462 |
| Protocol serial number | N0234166115 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK) |
| Funder | North Bristol NHS Trust (UK) NHS R&D Support Funding |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 28/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Kim Davenport
Scientific
Scientific
North Bristol NHS Trust
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Renal calculi |
| Intervention | Consecutive patients with renal calculi attending for lithotripsy will be randomised to receive treatment at either 60 or 120 shock waves per minute. The shock wave lithotripsy treatment will be given using the current protocols, with patient care being altered in no other way. Patients will be reviewed after 3 months with a KUB X-ray, and retreated to a maximum of three treatments if there are remaining fragments greater than 4mm. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | 100 adults |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2002 |
| Date of final enrolment | 01/08/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
North Bristol NHS Trust
Bristol
BS10 5NB
United Kingdom
BS10 5NB
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2006 | Yes | No |
