Condition category
Urological and Genital Diseases
Date applied
20/12/2006
Date assigned
17/08/2007
Last edited
17/08/2007
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

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes