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临床试验/NCT04538170
NCT04538170已完成不适用

Neuropathic Pain After Orchidectomy and Sex Reassignment Surgery

University Hospital Tuebingen1 个研究点 分布在 1 个国家目标入组 423 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
423
试验地点
1
主要终点
Incidence of Phantom Pain

研究概览

简要总结

Phantom pain is associated with cortical reorganization after amputation. This phenomenon should not play a role in transsexual women, since the cortical representation of the male sex organs is presumably altered. The study investigates the incidence of phantom pain in this patient population.

For this study the following question should be investigated:

Is the incidence of phantom pain and local chronic postsurgical pain lower in sex reassignment surgery from male to female compared to inguinal tumor orchidectomy?

详细描述

Phantom pain is a common and much studied phenomenon after amputation.The loss of visceral organs is also associated with phantom pain. Under entirely different conditions than the removal of a tumorous testicle, sex reassignment surgery from male to female sex occurs in transsexual women. In this operation, parts of the penis and both testicles are removed and a plastic surgical transformation is made into a female genital.The surgical trauma is greater compared to an orchidectomy.

The sex reassignment surgery is expressly desired, the amputated tissues are rejected or perceived as not belonging to the patient's own body and thus do not appear as a loss. The group of patients with tumor orchidectomy acts as a control group.

In addition to the incidence of phantom pain and chronic local postoperative pain in comparison between the two groups, the secondary objectives of the study were defined as the occurrence of phantom pain, the type of pain and the intensity of pain.

Two patient groups were compared, the group after sex reassignment surgery (GAC) and the group after inguinal orchidectomy for testicular tumor (ORC).

A total of 265 transgender women were written to, 46 of whom had undergone surgery in Tübingen and 219 in Munich. The operations took place between 2002 and 2014.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • Surgery at least 6 month before data collection
  • german speaking

排除标准

  • 未提供

结局指标

主要结局

Incidence of Phantom Pain

时间窗: a minimum of 6 month post-surgery up to 5 years postsurgery

Number of patients with phantom pain of testis

次要结局

  • Incidence of Chronic Postoperative Pain(a minimum of 6 month post-surgery up to 5 years postsurgery)
  • Functional Outcome(a minimum of 6 month post-surgery up to 5 years postsurgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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