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

NCT ID: NCT04314141

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

143 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-15

Study Completion Date

2020-11-14

Brief Summary

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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.

Detailed Description

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Conditions

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Phalloplasty Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Transgender patients

Transgender patients who carry out sex reassignment surgery.

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

Intervention Type PROCEDURE

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

Cismale patients

Cismale patients who carry out surgery to correct a congenital or acquired lack of penis.

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

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

73 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Urology Department, Hospices Civis de Lyon

Pierre-Bénite, , France

Site Status

Countries

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France

References

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Paganelli L, Morel-Journel N, Carnicelli D, Ruffion A, Boucher F, Maucort-Boulch D, Paparel P, Terrier M, Neuville P. Determining the outcomes of urethral construction in phalloplasty. BJU Int. 2023 Mar;131(3):357-366. doi: 10.1111/bju.15915. Epub 2022 Oct 26.

Reference Type BACKGROUND
PMID: 36221955 (View on PubMed)

Pelette R, Morel-Journel N, Carnicelli D, Ruffion A, Paganelli L, Vacheron CH, Terrier M, Madec FX, Neuville P. Functional outcomes after supra-pubic phalloplasty. J Plast Reconstr Aesthet Surg. 2024 Dec;99:263-270. doi: 10.1016/j.bjps.2024.09.065. Epub 2024 Sep 20.

Reference Type DERIVED
PMID: 39393169 (View on PubMed)

Other Identifiers

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69HCL19_0759

Identifier Type: -

Identifier Source: org_study_id

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