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临床试验/NCT07020390
NCT07020390招募中不适用

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

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2025年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
450
试验地点
1
主要终点
The Quality of Recovery Score (QoR-40)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

The Quality of Recovery Score (QoR-40)

时间窗: 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.

次要结局

  • Patient satisfaction and surgeon satisfaction(Postoperative day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gamze Talih

Principal Investigator

TC Erciyes University

研究点 (1)

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