Clinical trial NCT07020390: Effect of Anesthesia Techniques on Quality of Recovery Scores in HOLEP Surgery
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 450
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 years or older who meet the eligibility criteria and are scheduled to undergo surgery for benign prostatic hyperplasia (BPH).

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for HOLEP surgery due to benign prostatic hyperplasia.
* Patients who consent to participate in the study.

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Quality of Recovery Score (QoR-40)
timeFrame: Baseline (preoperative) and postoperative day 1
Secondary outcomes:
measure: Patient satisfaction and surgeon satisfaction
timeFrame: Postoperative day 1
Other outcomes:
Locations:
city: Melikgazi
country: Turkey
facility: Erciyes University
state: Kayseri
Study officials:
References: