HoLEPNCT07020390
Effect of Anesthesia Techniques on Quality of Recovery Scores in HOLEP Surgery
An observational study of HoLEP and QoR-40, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study is to evaluate the effects of different anesthesia techniques on the quality of recovery (QoR) and patient satisfaction in male patients, typically older adults with benign prostatic hyperplasia, undergoing Holmium Laser Enucleation of the Prostate (HoLEP). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HoLEP, QoR-40, Anesthesia, General
- What is being tested?
- Anesthesia method
- Type of treatment
- Surgery or procedure
- How many people
- 450 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2025to 15 Jun 2026
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years or older who meet the eligibility criteria and are scheduled to undergo surgery for benign prostatic hyperplasia (BPH).
Who may be able to join
- Patients scheduled for HOLEP surgery due to benign prostatic hyperplasia.
- Patients who consent to participate in the study.
Who cannot join
- Refusal to participate in the study
- Presence of cognitive impairment
- Use of psychoactive medications
- Failure of the intraoperative anesthesia technique and necessity to change the anesthesia method
- Requirement for reoperation or admission to the intensive care unit
- Voluntary withdrawal from the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University
Melikgazi, Kayseri
Gamze Talih, +905447604780, gamzetalih@gmail.com
About this study
Official title: The Effect of Anesthesia Techniques on Quality of Recovery (QoR-40) Scores in Benign Prostatic Hyperplasia (Holmium Laser Enucleation of the Prostate - HoLEP) Surgery: A Cross-Sectional, Observational, Prospective Study
The aim of this observational study is to evaluate the effects of different anesthesia techniques on the quality of recovery (QoR) and patient satisfaction in male patients, typically older adults with benign prostatic hyperplasia, undergoing Holmium Laser Enucleation of the Prostate (HoLEP).
Participants will undergo HoLEP surgery under one of three anesthesia techniques-general, spinal, or combined spinal-epidural anesthesia-and will complete the QoR-40 questionnaire both before and after the surgery.
Read the detailed description
These patients will be informed about the preoperative study and the Quality of Recovery 40 (QoR-40) scoring scale will be applied by the responsible researcher preoperatively and within 24 hours postoperatively, and the values will be recorded. The anesthesia method of the patients will be determined as determined routinely according to the patient's age, additional diseases, duration of surgery, and patient preference and will be applied by an experienced anesthesiologist. Routine intraoperative follow-ups of all patients will be performed. Surgeries completed without any complications will be taken to the recovery unit at the end of the procedure, and stable patients will be transferred to the ward. In patients whose ward follow-ups continue routinely, catheter-related bladder discomfort will be evaluated within 24 hours postoperatively, postoperative patient and surgeon satisfaction will be evaluated according to the 5-point Likert scale, and the QoR-40 score will be recorded. Postoperative pain levels and analgesic needs will be recorded. Parameters will be compared by dividing into groups according to the anesthesia method.
- Conditions
- HoLEP, QoR-40, Anesthesia, General, Anesthesia,Spinal, Anesthesia; Combine Spinal and Epidural
- Being tested
- Anesthesia method
- Keywords
- HoLEP, Quality of recovery (QoR-40), Patient satisfaction, Spinal anesthesia, General anesthesia, Benign prostatic hyperplasia, spinal-epidural anesthesia
- Medical subject headings
- Patient Satisfaction, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia methodProcedure or surgery
Patients will be divided into subgroups according to different anesthesia methods (general, spinal, and combined spinal-epidural anesthesia) and compared in terms of recovery quality (QoR-40) and other parameters.
| Study group | Role | What they receive |
|---|---|---|
| Patients who undergoing HOLEP under different anesthesia methods | Not described Receives: Procedure: Anesthesia method |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Quality of Recovery Score (QoR-40)
The QoR-40 is a self-rated questionnaire that consists of 40 items to evaluate the pain levels and physical and emotional state of patients, comprising five subscales: emotional state (n = 9), physical comfort (n = 12), patient support (n = 7), physical independence (n = 5), and pain (n = 7). Each item is scored on a five-point Likert scale ranging from 1 to 5. The scores for the subscales are given by the sum of the corresponding items, and the total score is computed by a summation of all items. The total score ranges from 40 to 200. Higher scores indicate higher levels of functioning or well-being.
Change in QoR-40 score from preoperative to postoperative day 1 to evaluate overall recovery quality.
Measured: Baseline (preoperative) and postoperative day 1
Secondary outcomes (1)
Patient satisfaction and surgeon satisfaction
Patient and surgeon satisfaction was rated using a 5-option Likert scale at postoperative day 1: 1 = very bad, 2 = bad, 3 = moderate, 4 = good and 5 = excellent.
Measured: Postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start20 Jun 2025
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HoLEPStudies of the same condition, open and under way.
- 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
- 450 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Talih, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020390
- Sponsor's protocol ID
- 2025/195
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anesthesia Techniques on Quality of Recovery (QoR-40) Scores in Benign Prostatic Hyperplasia (Holmium Laser Enucleation of the Prostate - HoLEP) Surgery: A Cross-Sectional, Observational, Prospective Study
- ClinicalTrials.gov ID
- NCT07020390
- Acronym / sponsor ID
- 2025/195
- Conditions
- HoLEP, QoR-40, Anesthesia, General, Anesthesia,Spinal, Anesthesia; Combine Spinal and Epidural
- Keywords
- HoLEP, Quality of recovery (QoR-40), Patient satisfaction, Spinal anesthesia, General anesthesia, Benign prostatic hyperplasia, spinal-epidural anesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 13 Jun 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.
The aim of this observational study is to evaluate the effects of different anesthesia techniques on the quality of recovery (QoR) and patient satisfaction in male patients, typically older adults with benign prostatic hyperplasia, undergoing Holmium Laser Enucleation of the Prostate (HoLEP).
Participants will undergo HoLEP surgery under one of three anesthesia techniques-general, spinal, or combined spinal-epidural anesthesia-and will complete the QoR-40 questionnaire both before and after the surgery.
Detailed description
These patients will be informed about the preoperative study and the Quality of Recovery 40 (QoR-40) scoring scale will be applied by the responsible researcher preoperatively and within 24 hours postoperatively, and the values will be recorded. The anesthesia method of the patients will be determined as determined routinely according to the patient's age, additional diseases, duration of surgery, and patient preference and will be applied by an experienced anesthesiologist. Routine intraoperative follow-ups of all patients will be performed. Surgeries completed without any complications will be taken to the recovery unit at the end of the procedure, and stable patients will be transferred to the ward. In patients whose ward follow-ups continue routinely, catheter-related bladder discomfort will be evaluated within 24 hours postoperatively, postoperative patient and surgeon satisfaction will be evaluated according to the 5-point Likert scale, and the QoR-40 score will be recorded. Postoperative pain levels and analgesic needs will be recorded. Parameters will be compared by dividing into groups according to the anesthesia method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who undergoing HOLEP under different anesthesia methods | – | Procedure: Anesthesia method |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older who meet the eligibility criteria and are scheduled to undergo surgery for benign prostatic hyperplasia (BPH).
Key inclusion criteria (2 listed)
- Patients scheduled for HOLEP surgery due to benign prostatic hyperplasia.
- Patients who consent to participate in the study.
Key exclusion criteria (6 listed)
- Refusal to participate in the study
- Presence of cognitive impairment
- Use of psychoactive medications
- Failure of the intraoperative anesthesia technique and necessity to change the anesthesia method
- Requirement for reoperation or admission to the intensive care unit
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 |
|---|---|---|
| Anesthesia methodPatients will be divided into subgroups according to different anesthesia methods (general, spinal, and combined spinal-epidural anesthesia) and compared in terms of recovery quality (QoR-40) and other parameters. | Procedure or surgery | Patients who undergoing HOLEP under different anesthesia methods |
Primary outcome
The Quality of Recovery Score (QoR-40)
Time frame: Baseline (preoperative) and postoperative day 1
The QoR-40 is a self-rated questionnaire that consists of 40 items to evaluate the pain levels and physical and emotional state of patients, comprising five subscales: emotional state (n = 9), physical comfort (n = 12), patient support (n = 7), physical independence (n = 5), and pain (n = 7). Each item is scored on a five-point Likert scale ranging from 1 to 5. The scores for the subscales are given by the sum of the corresponding items, and the total score is computed by a summation of all items. The total score ranges from 40 to 200. Higher scores indicate higher levels of functioning or well-being. Change in QoR-40 score from preoperative to postoperative day 1 to evaluate overall recovery quality.
1 secondary outcome
Patient satisfaction and surgeon satisfaction
Time frame: Postoperative day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for HoLEP
Recruiting
A Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)
BPH (Benign Prostatic Hyperplasia), HoLEP (Holmium Laser Enucleation of Prostate)
Active, not recruiting
The Effect of Pelvic Muscle Exercises on Urinary Incontinence in Patients Undergoing HoLEP Surgery.
Holep Surgery, Pelvic Floor Exercises
Not yet recruitingObservational study
Metabolic and Clinical Effects of Hyperchloremia During HoLEP Surgery.
HoLEP (Holmium Laser Enucleation of Prostate), Hyperchloremia
Recruiting
Educational Discharge Video Impact on Post-Operative Healthcare Utilization After HoLEP
HoLEP, Patient Satisfaction
Active, not recruiting
Evaluation of the Impact of Preoperative Pelvic Floor Exercise on Incontinence After Laser Enucleation of the Prostate: a Feasibility Study.
BPH (Benign Prostatic Hyperplasia), Incontinence, Urinary
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.
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 HoLEP and QoR-40, run by TC Erciyes University 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 1 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gamze Talih (+905447604780, gamzetalih@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Quality of Recovery Score (QoR-40) (time frame: Baseline (preoperative) and postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.