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

NCT07020390 | Recruiting

• 1 other identifier: 2025/195
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

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.

  Baseline (preoperative) and postoperative day 1

Secondary Outcomes (1)

• Patient satisfaction and surgeon satisfaction

  Postoperative day 1

Study Arms (1)

Patients who undergoing HOLEP under different anesthesia methods

Procedure: Anesthesia method

Interventions

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.

Patients who undergoing HOLEP under different anesthesia methods

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only individuals have biologically male anatomy relevant to the procedure are eligible to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Melikgazi, Kayseri, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Patient Satisfaction; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Gamze Talih

CONTACT

+905447604780; gamzetalih@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 13, 2025
• Study Start: June 20, 2025
• Primary Completion: March 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)