Condition category
Urological and Genital Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
11/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr T Whittlestone

ORCID ID

Contact details

C/O Research & Effectiveness Department
Level 1
The Old Building
Bristol Royal Infirmary
Malborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 3473
r&eoffice@ubht.swest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0264146222

Study information

Scientific title

The effect of nerve sparing anterior resection on erectile function and the prospect of therapeutic early intervention: a randomised controlled trial

Acronym

Study hypothesis

The effect of a combination of nerve sparing resection and therapy with sildenafil on function following anterior resection.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Erectile dysfunction

Intervention

Patients undergoing anterior resection to be randomised between sildenafil versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Sildenafil

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/1999

Overall trial end date

25/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with rectal carcinoma

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/10/1999

Recruitment end date

25/12/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

C/O Research & Effectiveness Department
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

United Bristol Healthcare NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/02/2016: No publications found, verifying study status with principal investigator