Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0234156276
Study information
Scientific title
Acronym
Study hypothesis
Effects of standard TURP using 5% glycine as irrigation with bipolar resection which can use normal saline as irrigation fluid.
Ethics approval
Not provided at time of registration
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Urological and Genital Diseases: Benign prostatic hyperplasia (BPH)
Intervention
Randomised to either bipolar resection with normal saline or TURP with glycine
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
ECG evidence of ischaemia, chest pain, cardiac arrhythmias, neurological symptoms, biochemistry results, haematology research
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/2004
Overall trial end date
01/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients scheduled for TURP under spinal anaesthesia will be approached.
Participant type
Patient
Age group
Not Specified
Gender
Male
Target number of participants
210
Participant exclusion criteria
Inability to give informed consent, general anaesthesia
Recruitment start date
01/12/2004
Recruitment end date
01/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
BUI
Bristol
BS16 1ND
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
Funders
Funder type
Government
Funder name
North Bristol NHS Trust (UK), 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
Basic results (scientific)
Publication list