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NCT Number: NCT07020390

Effect of Anesthesia Techniques on Quality of Recovery Scores in HOLEP Surgery

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.

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Key information

Conditions

HoLEP Anesthesia, General Anesthesia,Spinal Anesthesia; Combine Spinal and Epidural Behavior Genital Diseases Genital Diseases, Male Health Behavior Male Urogenital Diseases Patient Satisfaction Prostatic Diseases Prostatic Hyperplasia QoR-40 Treatment Adherence and Compliance Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Erciyes University

Melikgazi, Kayseri, Turkey (Türkiye)

Location status: Recruiting

Location contact

Gamze Talih

CONTACT

[email protected]

+905447604780

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anesthesia method

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient satisfaction and surgeon satisfaction

    Time frame: Postoperative day 1

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gamze Talih

CONTACT

[email protected]

+905447604780

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 13, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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