About this trial
The purpose of this study is to determine if applying a single dose of topical estrogen cream in the operating room at the end of your hysterectomy (removal of uterus and cervix) improves the postoperative experience with bleeding and potential symptoms of dysphoria (a feeling of discomfort or distress). Topical estrogen cream is sometimes used if patients have increased risk of bleeding with surgery but is not currently utilized in a consistent way. This study aims to answer the question of whether this is a helpful treatment and should be included in standard postoperative care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Gender diverse/transgender men
Age 18 or older
Have been on testosterone for at least 6 months with plan to undergo gender-affirming hysterectomy and are willing to be randomized to the use of topical estrogen postoperatively.
Have stable physical and mental health
Disqualifiers
Under age 18
Have not been on testosterone for at least 6 months prior to planned hysterectomy
Known allergy to topical estrogen
Trial design
Parallel
Treatments tested in this trial
Use of topical estradiol
DrugThe investigators will conduct a double blinded randomized control pilot trial. Participants will be randomized in 1:1 fashion to either receive no treatment or receive 2g of estradiol cream, placed after clearing the vaginal vault of any blood and discharge, at the conclusion of the surgery.
No intervention
Other interventionThis arm will not receive estradiol or other cream
Treatment groups
Trial outcomes
Primary outcomes
Evaluate the efficacy of one-time topical estrogen application for reducing postoperative health system contacts for vaginal bleeding in the first two weeks post hysterectomy.
The investigators hypothesize that administration of postoperative estrogen cream vaginally in the operating room will decrease the need for health system contact for bleeding in the initial postoperative period. Patients will be asked to complete a brief email survey on postoperative days: 1, 3, 7, \& 14 as well as at final postoperative visit \~42 days. This survey will target multiple things Outcome 1: Quantity of bleeding Determined by patient report: 1) small amount of spotting with wiping; 2) Staining pad, changing every 3-4 hours; 3) Bleeding like a light period; 4) Passing clots/heavy bleeding Additionally, chart review will be completed to assess for ED visits, office phone calls, MyChart Messages and any after-hours pages will be recorded.
Examine the impact of topical estrogen application on postoperative healing as defined by number of days of bleeding and patient Quality of Life Measures.
The investigators hypothesize that this intervention will demonstrate improved patient bleeding and dysphoria symptoms during the postoperative recovery period. The investigators will also measure mental health impact. Pre and postoperative Vanderbilt Mini Patient-Reported Outcome Measure - Gender (VMP-G)) scores will be obtained. This is a validated tool that assesses gender identity and gender affirming procedures as well as quality of life, self-concept, satisfaction, and gender dysphoria. (Hung 2023).
Other outcomes
Evaluate the efficacy of one-time topical estrogen application for reducing postoperative health system contacts for vaginal bleeding in the first two weeks post hysterectomy.
Additional outcomes: Outcome 2: Total days of postoperative bleeding (patient report) Outcome 3: Pain Scores on 0-10 scale at following intervals: postoperative days: 1, 3, 7, \& 14 as well as at final postoperative visit \~42 days. Outcome 4: Types and doses of pain medication taken Outcome 5: Worsening dysphoria symptoms (yes/no)
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