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

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Surgery
Phalloplasty

Treatments

Procedure: Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplasty

Study type

Observational

Funder types

Other

Identifiers

NCT04314141
69HCL19_0759

Details and patient eligibility

About

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.

Enrollment

143 patients

Sex

Male

Ages

20 to 73 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

143 participants in 2 patient groups

Transgender patients
Description:
Transgender patients who carry out sex reassignment surgery.
Treatment:
Procedure: Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplasty
Cismale patients
Description:
Cismale patients who carry out surgery to correct a congenital or acquired lack of penis.
Treatment:
Procedure: Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplasty

Trial contacts and locations

1

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Central trial contact

Nicolas MOREL-JOURNEL, MD; Paul NEUVILLE

Data sourced from clinicaltrials.gov

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