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临床试验/NCT06969326
NCT06969326招募中3 期

Topical Estrogen: Brief Intervention to Improve Postoperative Experience for Transgender Men Undergoing Hysterectomy

Women and Infants Hospital of Rhode Island1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
48
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

OBJECTIVES, SPECIFIC AIMS, BACKGROUND Vaginal bleeding causes significant dysphoria in many transgender men. The goal of hysterectomy for many patients is to eliminate the risk of bleeding, but the initial postoperative period often involves postoperative spotting and bleeding for patients, worsening the dysphoria around the time of surgery. Some patients have significant vaginal atrophy secondary to testosterone use, which is likely exacerbating this issue. Unfortunately, application of vaginal estrogen is messy and can worsen dysphoria symptoms for transgender individuals, making it not ideal for home use in the pre and postoperative periods.

Postoperative bleeding often prompts contacts with the health care system, especially when patients are experiencing dysphoria. These health system contacts are costly to patients, providers, and clinics particularly when the bleeding does not require intervention. Therefore, the investigators propose to pilot a trial of immediate postoperative intravaginal estrogen to prevent postoperative bleeding and decrease resulting health system contacts.

This pilot study will help to inform current practices about a novel process to decrease postoperative bleeding and dysphoria. This will help determine whether a simple intraoperative medication administration can improve the postoperative experience for patients and should help contribute data to guide future research in a patient population that has been under studied.

SIGNIFICANCE Bleeding related dysphoria is a common occurrence for many transmasculine individuals. A recent study of transgender adolescents demonstrated 93% had increased gender dysphoria or distress related to menses with many seeking care for menstrual management to achieve amenorrhea. (Schwartz 2022) Many patients achieve amenorrhea with initiation of testosterone and transgender patients are typically maintained on testosterone therapy for at least 6 months prior to gender affirming hysterectomy. Postoperative bleeding after hysterectomy, even in a well counseled patient, can be a dysphoric experience to manage in the postoperative period and impact patient satisfaction.

A recent study examined incidence and management of postoperative bleeding after gender affirming hysterectomy (GAH) which showed over 52% of the cohort called the clinic to report postoperative vaginal bleeding concerns. (Cipres 2023) Results showed that 88% had spotting or light bleeding requiring 1-2 pads per day in the first week after surgery. Patients who had had preoperative menstrual suppression had a higher (60%) frequency of postoperative bleeding concerns. Examinations revealed atrophy and granulation tissue as the source of bleeding. The authors hypothesize this was due to impaired tissue healing from the exogenous testosterone resulting in tissue friability and granulation tissue. (Cipres 2023) As vaginal bleeding could worsen gender dysphoria, these findings support the need for patient counseling on postoperative bleeding expectations and identification of interventions to reduce vaginal bleeding after GAH. Another recent retrospective study also demonstrated a higher rate of vaginal laceration during GAH compared to cisgender cohort (90% vs. 4.6%), along with increased use of electronic medical record (EMR) messages or calls for vaginal bleeding (27 vs 15%). (Pando 2024)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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
  • •No contraindications to estrogen therapy
  • •Must be proficient in English or Spanish
  • •Must have access to a device to receive text messages for study follow up
  • •Must agree to allow their medical data to be used for research purposes

排除标准

  • •Under age 18
  • •Have not been on testosterone for at least 6 months prior to planned hysterectomy
  • •Known allergy to topical estrogen

研究组 & 干预措施

Estradiol

Experimental

Application of topical estradiol at conclusion of surgery

干预措施: Use of topical estradiol (Drug)

Placebo

Placebo Comparator

Standard surgical treatment will be provided

干预措施: No intervention (Other)

结局指标

主要结局

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.

时间窗: 2 weeks

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.

时间窗: 6 weeks

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).

次要结局

未报告次要终点

研究者

发起方
Women and Infants Hospital of Rhode Island
申办方类型
Other
责任方
Principal Investigator
主要研究者

Beth Cronin

Division Director, Division of General Obstetrics and Gynecology

Women and Infants Hospital of Rhode Island

研究点 (1)

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