Educational Handout for Sex Reassignment Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to help people understand the pros and cons of keeping or removing ovaries during gender-affirming surgery. Before their surgical consultation, participants will receive an educational handout explaining the benefits and risks involved. The trial is designed for transgender or non-binary individuals assigned female at birth who seek a hysterectomy (surgical removal of the uterus), with or without an oophorectomy (removal of the ovaries). Participants should speak English and must not have already had their ovaries removed. Additionally, a standardized counseling approach will ensure consistent information delivery. As an unphased trial, this study offers participants the chance to contribute to valuable research that can improve decision-making in gender-affirming surgeries.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that this educational handout is safe?
Research has shown that the counseling methods used before gender-affirming surgeries are generally well-received. These methods help ensure that patients are informed and prepared for their surgery. Specifically, studies have found that 91% of transgender women reported a better quality of life after surgeries like vaginoplasty. Satisfaction with the results is usually high among transgender and gender-diverse people.
Overall, these counseling methods aim to improve mental health and quality of life. While the risks can vary depending on the specific surgery, focusing on informed decision-making and readiness helps reduce negative effects. This suggests that the counseling approach is safe and beneficial for those considering gender-affirming surgeries.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores the impact of an educational handout combined with a survey on patients undergoing sex reassignment surgery. Unlike the standard approach which may rely primarily on verbal counseling, this method provides written materials that can be reviewed at the patient's own pace. This could enhance understanding and retention of important information. By comparing this approach to standard counseling, researchers aim to find out whether the handout improves patient preparedness and satisfaction with their surgical experience.
What evidence suggests that this educational handout is effective for sex reassignment surgery?
Research has shown that transgender patients are generally very satisfied with their surgical results when evaluated at least a year after surgery. Studies have found that combining gender-affirming hormone therapy (GAHT) with gender-affirming surgery (GAS) is safe and effective, with many reporting higher satisfaction. Evidence suggests these surgeries can improve or even eliminate gender dysphoria, which is the distress from a mismatch between one's gender identity and assigned sex, as well as other mental health issues like alcohol and tobacco use. Providing gender-affirming care, including counseling and education, can also improve quality of life and reduce stigma. Overall, these treatments enhance mental health and life satisfaction for transgender individuals.
In this trial, participants will receive either a standardized counseling approach or an educational handout, with some also completing a survey. These interventions aim to assess the impact of educational materials on patient outcomes and satisfaction.678910Who Is on the Research Team?
Meredith Wise
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for transmasculine individuals planning to undergo gender-affirming surgery, specifically a hysterectomy. The study seeks participants who are considering whether to retain or remove their ovaries during the procedure.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Education
Participants receive an educational handout reviewing the benefits and risks of retaining ovaries vs removing them prior to surgical consultation
Follow-up
Participants are monitored for decisional conflict after receiving the educational handout
What Are the Treatments Tested in This Trial?
Interventions
- Standardized Counseling Approach
Trial Overview
The trial is testing the effectiveness of an educational handout that explains the pros and cons of keeping or removing ovaries in transmasculine patients before they consult with their surgeon.
How Is the Trial Designed?
2
Treatment groups
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Citations
Surgical satisfaction and quality of life outcomes reported ...
Studies suggest that most transgender patients are satisfied with surgical outcomes when assessed at least one-year post-surgery.
Maximizing surgical outcomes with gender affirming ...
GAHT has been shown to be safe and effective with concurrent GAS, with higher rates of satisfaction reported among those individuals undergoing GAS with GAHT ...
Analysis of Gender-Affirming Surgeries to Improve ...
Our review evaluated 11 studies that concluded that GD improved or resolved along with other mental health disorders, eg, alcohol use, tobacco ...
Developing a core outcome set for gender-affirming ...
A systematic review of psychosocial functioning changes after gender-affirming hormone therapy among transgender people. Nat Hum Behav. 2023 ...
Provision of gender-affirming care for trans and ...
Our findings indicate that provision of gender-affirming care may improve quality of life, stigma, utilization of health services, and mental health for trans ...
Readiness assessments for gender-affirming surgical treatments
The criteria in this model focus on informed consent, the social determinants of health, being physically ready for surgery, and putting measurable goals on ...
Standardized research methods to improve gender- ...
Research has demonstrated that 91% of transgender women have reported an improved quality of life after undergoing vaginoplasty and nearly 85% ...
Study Details | NCT07324967 | A Standardized Counseling ...
A Standardized Counseling Approach to Preoperative Education in Transmasculine Individuals Receiving Gender-affirming Surgery. ClinicalTrials ...
Standards of Care for Transgender and Gender Diverse ...
Risks differ by procedure, but studies estimate that overall satisfaction with postoperative results among transgender and gender diverse people ...
Provision of gender-affirming care for trans and ...
Five studies evaluated changes in mental health outcomes following gender affirming surgery40,43,47,49,57: some found improvements in mental health while ...
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