Surgical and Functional Outcomes, Quality of Life and Patient's Satisfactions Who Have Undergone a Phalloplasty Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Change of Sexual quality of life of patients with phalloplasty (SEAR questionnaire) from the pre-surgery (Baseline) to one year or more after surgery
研究概览
简要总结
The phalloplasty is a reconstruction technique, consisting of the neophallus creation.
It is performed in transgender patients in sex reassignment surgery, or in cismale patients to correct a congenital or acquired lack of penis.
There are many surgical techniques, but none is optimal. Surgical and functional outcomes, quality of life and patient's satisfactions with phalloplasty are missing in the international literature.
Urological center of Lyon is a reference center of this kind of surgery and has the possibility to evaluate that.
In this study, 124 transgender and 19 cismale patients with phalloplasty are eligible.
This study will allow us to adapt our practice to the patient's return and improve the information given to patients before their surgery.
It will also improve our surgical techniques, depending on the results achieved.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 73 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Major patients
- •Patients who have undergone a phalloplasty surgery in the University Lyon Sud Hospital or Croix Rousse Hospital, between 1 January 2007 and 31 October 2018
- •Patients with at least one year of back on their surgery procedures
- •Transgender patients whose reassignment surgery was validated by a minimum of three members of GRETTIS (Groupe de Recherche, d'Etude et de Traitement des Troubles de l'Identité Sexuelle), including a psychiatrist Or Patients cis males with congenital malformations, or having suffered a total or partial amputation of verge
- •Patients who do not oppose orally to participate in the study, after information
- •Patients who have given their consent for the audio recording for patients taking part in semi - directive interviews
排除标准
- •Minor patients or patients under legal protection
- •Refusal to participate in the study
- •No understanding of the French language
结局指标
主要结局
Change of Sexual quality of life of patients with phalloplasty (SEAR questionnaire) from the pre-surgery (Baseline) to one year or more after surgery
时间窗: One year or more after surgery (baseline)
Sexual quality of life is evaluated with the SEAR (self esteem and relationship questionnaire), noted in 100. It explores different fields of sexual life (sexual report, confidence, self esteem, general relationship with the partner).
次要结局
未报告次要终点