Contact information
Type
Scientific
Primary contact
Dr Linus Okeke
ORCID ID
Contact details
Urology Division
Department of Surgery
College of Medicine
University of Ibadan
University College Hospital
Ibadan
PMB 5116
Nigeria
+234 (0)80 3383 0052
liokeke@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TURP/WARM 001
Study information
Scientific title
Acronym
Study hypothesis
Transurethral resection of the prostate gland with irrigation and intravenous fluids at room temperature as is currently performed often leads to a drop in the core body temperature with all the possible consequences of hypothermia. Studies have shown that with the use of isothermic irrigation fluids, the drop in the core body temperature is less but still occured in some patients. My hypothesis is that if the intravenous fluid is also isothermic before delivery into the patient along with isothermic irrigation fluid, the core body temperature of the patients SHOULD NOT drop during transurethral resection of the prostate gland.
Ethics approval
Approval received from the University of Ibadan (UI)/University College Hospital (UCH) Institutional Review Committee on the 16th August 2007 (ref: UI/IRC/07/0007).
The patients will be fully informed of the study and their written informed consent obtained. There will be NO penalty for refusal to consent.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Benign Prostatic Hyperplasia (BPH)
Intervention
Allocation of patients to one of three study groups will be by the picking of a ballot by the patient from a non-transparent jar containing prelabelled squeezed slips containing the group to which the patient will be assigned.
Intervention: TURP using isothermic intravenous and isothermic irrigation fluids
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Hypothermia will NOT occur in the study group.
Secondary outcome measures
The patients will be more comfortable, have less morbidity and have a shorter hospital stay.
Overall trial start date
01/01/2001
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with benign prostatic hyperplasia who have obstructive symptoms and are already scheduled to have Transurethral Resection of their Prostate gland (TURP).
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
40 in each of three groups
Participant exclusion criteria
Patients with co-morbid conditions such as:
1. Diabetes mellitus
2. Inguinal hernia
3. Vesical calculi
4. Asthma
5. Axial skeletal or hip deformities which interfered with Lloyd Davis positioning
6. Recent cerebrovascular accidents
Recruitment start date
01/01/2001
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Nigeria
Trial participating centre
Urology Division
Ibadan
PMB 5116
Nigeria
Sponsor information
Organisation
Individual sponsor (Nigeria)
Sponsor details
Dr Linus Okeke
Urology Division
Department of Surgery
College of Medicine
University of Ibadan
University College Hospital
Ibadan
PMB5116
Nigeria
liokeke@yahoo.com
Sponsor type
Other
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded trial (Nigeria)
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