Effect of warm intravenous and irrigating fluids on body temperature during transurethral resection of the prostate gland

ISRCTN ISRCTN30362207
DOI https://doi.org/10.1186/ISRCTN30362207
Secondary identifying numbers TURP/WARM 001
Submission date
20/12/2006
Registration date
17/08/2007
Last edited
29/10/2021
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

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Linus Okeke
Scientific

Urology Division
Department of Surgery
College of Medicine
University of Ibadan
University College Hospital
Ibadan
PMB 5116
Nigeria

Phone +234 (0)80 3383 0052
Email liokeke@yahoo.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleEffect of warm intravenous and irrigating fluids on body temperature during transurethral resection of the prostate gland
Study objectivesTransurethral 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(s)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.
Health condition(s) or problem(s) studiedBenign Prostatic Hyperplasia (BPH)
InterventionAllocation 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 typeOther
Primary outcome measureHypothermia will NOT occur in the study group.
Secondary outcome measuresThe patients will be more comfortable, have less morbidity and have a shorter hospital stay.
Overall study start date01/01/2001
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants40 in each of three groups
Total final enrolment120
Key inclusion criteriaPatients with benign prostatic hyperplasia who have obstructive symptoms and are already scheduled to have Transurethral Resection of their Prostate gland (TURP).
Key exclusion criteriaPatients 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
Date of first enrolment01/01/2001
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Nigeria

Study participating centre

Urology Division
Ibadan
PMB 5116
Nigeria

Sponsor information

Individual sponsor (Nigeria)
Other

Dr Linus Okeke
Urology Division
Department of Surgery
College of Medicine
University of Ibadan
University College Hospital
Ibadan
PMB5116
Nigeria

Email liokeke@yahoo.com

Funders

Funder type

Other

Investigator initiated and funded trial (Nigeria)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 18/09/2007 29/10/2021 Yes No

Editorial Notes

29/10/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.