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临床试验/NCT06362083
NCT06362083招募中不适用

Construction of a Clinical Urethral Stricture Database for a Prospective Longitudinal Cohort Study

Medical University of Graz1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Success rate of urethral reconstructive surgeries

研究概览

简要总结

Establishment of a clinical urethral stricture database for a prospective longitudinal cohort study.

详细描述

The aim is to establish a prospective clinical database of patients undergoing urethral surgery due to urethral stricture. In addition to pre-operative basic data, intraoperative and postoperative data, as well as follow-up data through questionnaires, are to be collected. The main objective is the prospective determination of success rates of the performed urethral surgeries in the short, medium, and long term. Furthermore, risk factors leading to failure (recurrence of urethral stricture) should be identified. Ultimately, the quality of life before and after urethral surgery is to be assessed in order to compare the applied procedures.

In today's reconstructive urethral surgery, there are few scientific surveys so far. Many of the applied techniques (therapy options) are based more on the experiences of individual surgeons than on a solid database, hence there are also different approaches. By evaluating prospective data and comparing individually applied surgical methods, the least complication-prone and most successful techniques are to be identified. The planned study aims to create an "efficacy-safety" profile for each urethral surgery technique. This will enable us in the future to not only provide improved (data-based) patient information but also to involve the patient better in the therapy decision. Thus, in the future, counseling and therapy for a young sexually active patient could differ from counseling for an older patient who is no longer sexually active, even with the same stricture length and location.

The analyses of the urethral database will thus enable us to internally validate therapy algorithms and provide personalized patient counseling.

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

  • All patients undergoing any of the following urethral surgeries are included:
  • Internal urethrotomy according to Sachse (endoscopic transurethral urethrotomy)
  • End-to-end anastomosis
  • Urethral plastic surgeries with oral mucosa graft (potentially penile skin)
  • Urethral plastic surgeries with mesh graft
  • Hypospadias corrections
  • Boutonniere
  • (Self) bougienage of the urethra

排除标准

  • Lack of capacity to consent

结局指标

主要结局

Success rate of urethral reconstructive surgeries

时间窗: Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years

Success is defined as a lack of stricture recurrence in the follow-up

次要结局

  • Complications of urethral reconstructive surgeries(Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years)
  • Health status after urethral reconstructive surgeries(Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years)
  • Sexual function after urethral reconstructive surgeries(Questionnaires to patients are captured 3, 6 an d12 months following surgery, and then every year put to 10 years)

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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