The effect of nerve sparing anterior resection on erectile function and the prospect of therapeutic early intervention
| ISRCTN | ISRCTN71503461 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71503461 |
| Secondary identifying numbers | N0264146222 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 09/03/2018
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr T Whittlestone
Scientific
Scientific
C/O Research & Effectiveness Department
Level 1, The Old Building
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
| Phone | +44 (0)117 928 3473 |
|---|---|
| r&eoffice@ubht.swest.nhs.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 contact details to request a participant information sheet |
| Scientific title | The effect of nerve sparing anterior resection on erectile function and the prospect of therapeutic early intervention: a randomised controlled trial |
| Study objectives | The effect of a combination of nerve sparing resection and therapy with sildenafil on function following anterior resection. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Erectile dysfunction |
| Intervention | Patients undergoing anterior resection to be randomised between sildenafil versus placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Sildenafil |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/1999 |
| Completion date | 25/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Patients with rectal carcinoma |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/10/1999 |
| Date of final enrolment | 25/12/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
BS2 8HW
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
Hospital/treatment centre
United Bristol Healthcare NHS Trust (UK)
No information available
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 |
Editorial Notes
09/03/2018: No publications found, verifying study status with principal investigator.
11/02/2016: No publications found, verifying study status with principal investigator
