Transurethral Resection of Prostate SyndromeNCT06790017
Hemoglobin-to-red Blood Cell Distribution Width Ratio and Hypothermia for Elderly Patient
An observational study of Transurethral Resection of Prostate Syndrome and Elderly (People Aged 65 or More), run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
As individuals age, they often enter a phase of increased "frailty." Elderly and frail patients represent a population that requires heightened sensitivity and close monitoring during surgical procedures. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Transurethral Resection of Prostate Syndrome, Elderly (People Aged 65 or More), General Anesthetic
- What is being tested?
- body temperature
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Apr 2025to 11 Jun 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Men only
- No healthy volunteers
- Older adult
Study population: Etlik City Hospital, Urology Operating Rooms
Who may be able to join
- Patients who provided informed consent.
- Patients scheduled for transurethral prostatectomy surgery.
- Patients classified as ASA-PS 1, 2, or 3.
- Male patients aged 65 years or older.
- Patients undergoing elective surgery.
- Patients receiving general anesthesia.
Who cannot join
- Patients who did not provide informed consent.
- Patients undergoing emergency surgery.
- Patients with conditions that disrupt thermoregulation (e.g., intracranial mass, peripheral vascular diseases, sepsis).
- Patients with a body temperature of <34℃ or >38℃ upon arrival at the preoperative waiting room.
- Patients who used heating methods other than the routine cotton cover in the preoperative waiting room.
- Patients who received additional heating methods other than the routinely applied intraoperative hot air blower drapes.
- Patients undergoing surgery under any type of anesthesia other than general anesthesia.
- Patients who were taken out of the operating room while intubated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temperature Measurement for Transurethral Prostatectomy Surgery in Elderly Patient
As individuals age, they often enter a phase of increased "frailty." Elderly and frail patients represent a population that requires heightened sensitivity and close monitoring during surgical procedures. This study aims to investigate the relationship between the Hemoglobin-to-Red Blood Cell Distribution Width (Hb/RDW) ratio and perioperative hypothermia in elderly patients undergoing transurethral prostatectomy. This is an observational study. Preoperative blood test results and intraoperative body temperature measurements of the patients will be recorded in our data forms.
- Conditions
- Transurethral Resection of Prostate Syndrome, Elderly (People Aged 65 or More), General Anesthetic
- Being tested
- body temperature
- Keywords
- elderly, hypothermia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body temperatureOther
Body temperature measurement will be performed in the preoperative and intraoperative periods.
| Study group | Role | What they receive |
|---|---|---|
| Low hemoglobin to red cell distribution width ratio (HRR) | Patients whose HRR rate is below 9.97 and are considered frail Receives: Other: body temperature | |
| High hemoglobin to red cell distribution width ratio (HRR) | Patients whose HRR ratio is above 9.97 and are considered non-frail Receives: Other: body temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Hypothermia
Perioperative hypothermia is defined as any core temperature less than 96.8°F (36.0°C)
Measured: 1 hour before anesthesia and intraoperative
Secondary outcomes (2)
Frailty
The relationship between hemoglobin to red cell distribution width ratio (HRR) and frailty
Measured: preoperative
Red blood cell distribution width
The relationship between red blood cell distribution width (RDW) and hypothermia
Measured: 1 hour before anesthesia and intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start9 Apr 2025
- Primary completion1 Jun 2025
- Study completion11 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Transurethral Resection of Prostate SyndromeStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gokcen Kulturoglu, Ankara Etlik City Hospital
- Investigators
- Gokcen KULTUROGLU, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790017
- Sponsor's protocol ID
- AESH-EK1-2024-0082
- Status last verified
- Jun 2025
- First submitted
- 9 Jan 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available on request from the corresponding author, (GK). The data are not publicly available due to our participants' informed consent forms.
Publications
Zhu M, Wei C, Yang X, Huang Y, Xu Y, Xiong Z. Lower haemoglobin-to-red blood cell distribution width ratio is independently associated with frailty in community-dwelling older adults: a cross-sectional study. BMJ Open. 2023 Jul 9;13(7):e069141. doi: 10.1136/bmjopen-2022-069141.
PubMed 37423632Qu J, Zhou T, Xue M, Sun H, Shen Y, Chen Y, Tang L, Qian L, You J, Yang R, Liu Y. Correlation Analysis of Hemoglobin-to-Red Blood Cell Distribution Width Ratio and Frailty in Elderly Patients With Coronary Heart Disease. Front Cardiovasc Med. 2021 Aug 27;8:728800. doi: 10.3389/fcvm.2021.728800. eCollection 2021.
PubMed 34513961
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temperature Measurement for Transurethral Prostatectomy Surgery in Elderly Patient
- ClinicalTrials.gov ID
- NCT06790017
- Acronym / sponsor ID
- AESH-EK1-2024-0082
- Conditions
- Transurethral Resection of Prostate Syndrome, Elderly (People Aged 65 or More), General Anesthetic
- Keywords
- elderly, hypothermia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As individuals age, they often enter a phase of increased "frailty." Elderly and frail patients represent a population that requires heightened sensitivity and close monitoring during surgical procedures. This study aims to investigate the relationship between the Hemoglobin-to-Red Blood Cell Distribution Width (Hb/RDW) ratio and perioperative hypothermia in elderly patients undergoing transurethral prostatectomy. This is an observational study. Preoperative blood test results and intraoperative body temperature measurements of the patients will be recorded in our data forms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low hemoglobin to red cell distribution width ratio (HRR) | – | Other: body temperaturePatients whose HRR rate is below 9.97 and are considered frail |
| High hemoglobin to red cell distribution width ratio (HRR) | – | Other: body temperaturePatients whose HRR ratio is above 9.97 and are considered non-frail |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Etlik City Hospital, Urology Operating Rooms
Key inclusion criteria (6 listed)
- Patients who provided informed consent.
- Patients scheduled for transurethral prostatectomy surgery.
- Patients classified as ASA-PS 1, 2, or 3.
- Male patients aged 65 years or older.
- Patients undergoing elective surgery.
Key exclusion criteria (8 listed)
- Patients who did not provide informed consent.
- Patients undergoing emergency surgery.
- Patients with conditions that disrupt thermoregulation (e.g., intracranial mass, peripheral vascular diseases, sepsis).
- Patients with a body temperature of <34℃ or >38℃ upon arrival at the preoperative waiting room.
- Patients who used heating methods other than the routine cotton cover in the preoperative waiting room.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| body temperatureBody temperature measurement will be performed in the preoperative and intraoperative periods. | Other | High hemoglobin to red cell distribution width ratio (HRR), Low hemoglobin to red cell distribution width ratio (HRR) |
Primary outcome
Perioperative Hypothermia
Time frame: 1 hour before anesthesia and intraoperative
Perioperative hypothermia is defined as any core temperature less than 96.8°F (36.0°C)
2 secondary outcomes
Frailty
Time frame: preoperative
Red blood cell distribution width
Time frame: 1 hour before anesthesia and intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Background: PubMed 37423632Zhu M, Wei C, Yang X, Huang Y, Xu Y, Xiong Z. Lower haemoglobin-to-red blood cell distribution width ratio is independently associated with frailty in community-dwelling older adults: a cross-sectional study. BMJ Open. 2023 Jul 9;13(7):e069141. doi: 10.1136/bmjopen-2022-069141.
- Background: PubMed 34513961Qu J, Zhou T, Xue M, Sun H, Shen Y, Chen Y, Tang L, Qian L, You J, Yang R, Liu Y. Correlation Analysis of Hemoglobin-to-Red Blood Cell Distribution Width Ratio and Frailty in Elderly Patients With Coronary Heart Disease. Front Cardiovasc Med. 2021 Aug 27;8:728800. doi: 10.3389/fcvm.2021.728800. eCollection 2021.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available on request from the corresponding author, (GK). The data are not publicly available due to our participants' informed consent forms.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gokcen KULTUROGLU principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transurethral Resection of Prostate Syndrome and Elderly (People Aged 65 or More), run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Hypothermia (time frame: 1 hour before anesthesia and intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06790017, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.