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 |
| Protocol serial number | TURP/WARM 001 |
| Sponsor | Individual sponsor (Nigeria) |
| Funder | Investigator initiated and funded trial (Nigeria) |
- 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
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 |
|---|---|
| liokeke@yahoo.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Effect of warm intravenous and irrigating fluids on body temperature during transurethral resection of the prostate gland |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
Hypothermia will NOT occur in the study group. |
| Key secondary outcome measure(s) |
The patients will be more comfortable, have less morbidity and have a shorter hospital stay. |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 120 |
| Total final enrolment | 120 |
| Key inclusion criteria | Patients with benign prostatic hyperplasia who have obstructive symptoms and are already scheduled to have Transurethral Resection of their Prostate gland (TURP). |
| Key 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 |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Nigeria
Study participating centre
Urology Division
Ibadan
PMB 5116
Nigeria
PMB 5116
Nigeria
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not 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.
