Gynaecological Gender-affirming Surgeries

Patient Reported Outcomes After Gynaecological Gender Surgeries

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06098781

Enrollment

Registered

2023-10-25

Start date

2022-09-02

Completion date

2025-06-01

Last updated

2023-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gender Dysphoria

Keywords

hysterectomy, colpectomy, vaginectomy, tubectomy, patient-reported outcome measure

Brief summary

The goal of this prospective cohort study is to learn about the patient report outcomes after gynaecological gender-affirming surgeries (i.e. hysterectomy, tubectomy, colpectomy) among trans-masculine and non-binary individuals (assigned female at birth). The main question it aims to answer are: • What is the experienced effect of gynaecological gender-affirming surgeries Participants will be asked to fill out a questionaire pre-operatively and 3,9 and 18 months post-operatively.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* assigned female at birth * scheduled to undergo gynaecological gender-affirming surgery (i.e. hysterectomy, ovariectomy, tubectomy and/or colpectomy)

Exclusion criteria

* age below 18 y/o * surgery combined with other surgeries (e.g. urethroplasty, metoidioplasty)

Design outcomes

Primary

Measure	Time frame	Description
Experienced effect on gender dysphoria	3& 9 months	On a scale of -5 to +5 the experienced effect on gender dysphoria
Experienced effect on gender dysphoria measured by GCLS	9 & 18 months	Comparison of GCLS score (gender congruence life satisfaction scale) pre-operatively and post-operatively

Secondary

Measure	Time frame	Description
Experienced effect on sexual experience	3& 9 months	On a scale of -5 to +5 the experienced effect on sexual experience
Surgical satisfaction	3& 9 months	—
Experienced effect on psychological well being	3 & 9 months	On a scale of -5 to +5 the experienced effect on psychological well being
Physical complaints post-operatively	3 & 9 months	physical complaints (bleeding, discharge, abdominal/pelvic pain, difficulty sitting, difficulty peeing, climacterial other complaints)
Recovery time postoperatively	3 months	Time to recovery of daily activities
Impact of health on satisfaction of life	3 & 9 months	Comparison of Short Form Health Survey (SF12) pre- and postoperatively
Experienced effect on confidence	3& 9 months	On a scale of -5 to +5 the experienced effect on confidence

Countries

Netherlands

Contacts

Primary ContactJudith AF Huirne, MD, PhD

secretariaat-vrouwenkliniek@amsterdamumc.nl020-5663654

Backup ContactNorah M van Mello, MD, PhD