Gynaecological Gender-affirming Surgeries

Recruiting

• Conditions: Gender Dysphoria

• Registration Number: NCT06098781
• Lead Sponsor: Amsterdam UMC, location VUmc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-02
• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-19
• Study First Posted: 2023-10-25
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-15
• Primary Completion: 2024-02-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 57

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Experienced effect on sexual experience	3& 9 months	On a scale of -5 to +5 the experienced effect on sexual experience
Experienced effect on psychological well being	3 & 9 months	On a scale of -5 to +5 the experienced effect on psychological well being
Experienced effect on confidence	3& 9 months	On a scale of -5 to +5 the experienced effect on confidence
Surgical satisfaction	3& 9 months
Impact of health on satisfaction of life	3 & 9 months	Comparison of Short Form Health Survey (SF12) pre- and postoperatively
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

Trial Locations

Locations (1)

Amsterdam UMC, Location VU Medical Center; 🇳🇱 Amsterdam, Netherlands