Gynaecological Gender-affirming Surgeries

Gender Dysphoria Clinical Trial

Official title:

Patient Reported Outcomes After Gynaecological Gender Surgeries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06098781
• Other study ID #: 2020.332
• Status: Recruiting
• Start date: September 2, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: November 2023
• Source: Amsterdam UMC, location VUmc
• Contact: Judith AF Huirne, MD, PhD
• Phone: 020-5663654
• Email: secretariaat-vrouwenkliniek[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: June 1, 2025
• Est. primary completion date: February 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Gender Dysphoria

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, Location VU Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Experienced effect on gender dysphoria	On a scale of -5 to +5 the experienced effect on gender dysphoria	3& 9 months
Primary	Experienced effect on gender dysphoria measured by GCLS	Comparison of GCLS score (gender congruence life satisfaction scale) pre-operatively and post-operatively	9 & 18 months
Secondary	Experienced effect on psychological well being	On a scale of -5 to +5 the experienced effect on psychological well being	3 & 9 months
Secondary	Experienced effect on confidence	On a scale of -5 to +5 the experienced effect on confidence	3& 9 months
Secondary	Experienced effect on sexual experience	On a scale of -5 to +5 the experienced effect on sexual experience	3& 9 months
Secondary	Surgical satisfaction		3& 9 months
Secondary	Impact of health on satisfaction of life	Comparison of Short Form Health Survey (SF12) pre- and postoperatively	3 & 9 months
Secondary	Physical complaints post-operatively	physical complaints (bleeding, discharge, abdominal/pelvic pain, difficulty sitting, difficulty peeing, climacterial other complaints)	3 & 9 months
Secondary	Recovery time postoperatively	Time to recovery of daily activities	3 months