Clinical trial NCT04314141: Surgical Outcomes, Quality of Life and Patient's Satisfactions With Phalloplasty
Official title: Surgical and Functional Outcomes, Quality of Life and Patient's Satisfactions Who Have Undergone a Phalloplasty Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Phalloplasty
Surgery
Keywords: phalloplasty
surgery
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 143
Sex: MALE
Minimum age (years): 20
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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, with at least one year of back on their surgery procedures.

Patients concerned with this surgery are :

* transgender patients whose reassignment surgery was validated by a minimum of three members of GRETTIS, including a psychiatrist.
* Patients cis males with congenital malformations, or having suffered a total or partial amputation of verge

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Minor patients or patients under legal protection
* Refusal to participate in the study
* No understanding of the French language

Primary outcomes:
measure: Change of Sexual quality of life of patients with phalloplasty (SEAR questionnaire) from the pre-surgery (Baseline) to one year or more after surgery
timeFrame: One year or more after surgery (baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Urology Department, Hospices Civis de Lyon
Study officials:
References: