Surgical Outcomes, Quality of Life and Patient's Satisfactions With Phalloplasty

Surgery Clinical Trial

— PHALLO  

Official title:

Surgical and Functional Outcomes, Quality of Life and Patient's Satisfactions Who Have Undergone a Phalloplasty Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04314141
• Other study ID #: 69HCL19_0759
• Status: Completed
• Start date: May 15, 2020
• Est. completion date: November 14, 2020

Study information

• Verified date: April 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: November 14, 2020
• Est. primary completion date: November 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 73 Years

Eligibility

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

Related Conditions & MeSH terms

• Phalloplasty
• Surgery

Intervention

Procedure:
• Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplasty
Send a questionnaire to patients to collect informations about: Sexual quality of life before and after the surgery Satisfaction after surgery Data collection in medical file : Surgery outcomes Functional outcomes

Locations

Country	Name	City	State
France	Urology Department, Hospices Civis de Lyon	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Sexual quality of life of patients with phalloplasty (SEAR questionnaire) from the pre-surgery (Baseline) to one year or more after surgery	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).	One year or more after surgery (baseline)