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临床试验/NCT05617261
NCT05617261Enrolling By Invitation不适用

Evaluating Patient Tolerability and Success for Penile and Scrotal Urologic Procedures Under Conscious Sedation: A Prospective Study

University of Manitoba1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年11月13日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
150
试验地点
1
主要终点
Patient reported tolerability

研究概览

简要总结

The goal of this observational study is to evaluate patient reported outcomes and tolerability of scrotal and penile urologic procedures under the administration of minimal conscious sedation. This will be assessed at 4-6 weeks post-procedure where patients will be followed up with a questionnaire assessing how well patients tolerated the procedure and if patients would opt for conscious sedation again in a similar, future procedure. The investigators will secondarily be assessing the associated cost savings as compared to having these procedures performed under general anesthesia at a tertiary care hospital.

详细描述

Background:

The current standard of care for the vast majority of urological procedures is the administration of general anesthesia, spinal anesthesia, or anesthesia-delivered sedation - requiring the operating room. However, this poses significant challenges associated with operating room costs, resources, and patient wait times. Given lengthy surgical backlogs, priority is focused on more acute conditions such as malignancies that require immediate intervention. Procedures for non-acute conditions, such as penile and scrotal procedures, have wait times that can exceed six months. Since most treatment for penile and scrotal cases tends to be surgical intervention, delays in these procedures may significantly negatively impact patients' sexual health, relationships, mental health, and quality of life. The ability to perform these procedures outside of the operating room using local anesthesia with or without conscious sedation may significantly reduce patient wait times and the costs of surgical intervention. Furthermore, the use of conscious sedation would allow for faster post-operative recovery, shorter procedural times, and decreased risks/side effects associated with general anesthesia.

Fields such as plastic surgery have successfully transitioned certain procedures into a clinic- based setting and the field of urology had also shown a similar interest. The investigators research team has been at the forefront of this transition - previously demonstrating the efficacy of distal ureteroscopy under nursing administered conscious sedation and other common urologic procedures. However, these studies were limited as they did not examine invasive scrotal and penile procedures, which have an extraordinary impact on the sexual health of patients.

Significance:

This project will provide evidence on the efficacy and characteristics of successful penile and scrotal procedures conducted under the administration of local anesthesia with or without conscious sedation. The findings of this study will help transition additional urological procedures into a clinic-based setting safely: improving the sexual and mental health of patients while decreasing cost, wait times, procedure duration, recovery times, and anesthetic-related complications.

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 over the age of 18
  • undergoing one of the previously mentioned procedures under local anesthesia with or without conscious sedation
  • having a minimum follow-up of 4-6 weeks.

排除标准

  • 未提供

结局指标

主要结局

Patient reported tolerability

时间窗: Standardized questionnaire will be administered to patients 4-6 weeks after their individual procedure.

Patient tolerability as assessed using a standardized questionnaire administered to patients. Key questions of interest are if patients would opt for conscious sedation for a repeat procedure or general anesthesia, recommend conscious sedation to a friend undergoing a similar procedure, and a scale question with self-reported tolerability ranging from 0-10 with a higher value corresponding to an excellent experience.

次要结局

未报告次要终点

研究者

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

PremalPatel

Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education

University of Manitoba

研究点 (1)

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