Effect of Anesthesia Techniques on Quality of Recovery Scores in HOLEP Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorTC Erciyes University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for HOLEP surgery due to benign prostatic hyperplasia.
Patients who consent to participate in the study.
Disqualifiers
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
Trial population
Patients aged 18 years or older who meet the eligibility criteria and are scheduled to undergo surgery for benign prostatic hyperplasia (BPH).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Anesthesia method
Procedure/SurgeryPatients 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.
Treatment groups
450 Participants
are divided into 1 treatment groupGroup A: Patients who undergoing HOLEP under different anesthesia methods1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (preoperative) and postoperative day 1Secondary 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.
Time frame
Postoperative day 1Sponsors and contacts
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Source ClinicalTrials.gov