Clinical trial NCT06816355: Exogenous Sex Hormones and PONV
Official title: Exogenous Sex Hormones and PONV: Evaluating Postoperative Nausea and Vomiting Risk in Transgender Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Nausea and Vomiting
Sex Hormone
Transgender
Keywords: Postoperative nausea and vomiting
sex hormone
estrogen
testosterone
transgender
Lead sponsor: Riverside University Health System Medical Center
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 7348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing orchiectomies, hysterectomies, or augmentation mammoplasties.

Brief summary: This study aims to investigate the rates of postoperative nausea and vomiting in transgender patients on hormone therapy compared to cisgender patients undergoing the same procedures (hysterectomy, orchiectomy, augmentation mammoplasty).

Detailed description: A retrospective cohort study will be performed using the TriNetX database. Cohorts were defined using Common Procedural Terminology and International Classification of Diseases-10 codes. Separate analyses will be performed for hysterectomies, orchiectomies, and augmentation mammoplasties. Patients will be excluded if they had a history of postoperative nausea and vomiting or a history of neoplasm for which the respective procedure would be indicated (e.g., uterine, cervical, testicular, or breast cancer). Transgender patients will be excluded if not on exogenous hormone therapy and cisgender patients will be excluded if on the same exogenous hormone therapy as their transgender counterparts. Patients will be divided into two groups (transgender group and cisgender group) based on whether they had a diagnosis of sex reassignment, transsexualism, or gender identity disorder. The cohorts will be propensity score-matched based on age, race/ethnicity, and tobacco use.

Eligibility criteria: Hysterectomy Cohort:

Inclusion:

- Patients who underwent hysterectomies.

Exclusion:

- Patients who had malignant neoplasm of the uterus, ovarian, cervical, endometrium, or adnexa.

Transgender Male Group

Inclusion:

* administered testosterone within 6 months and 1 day before their hysterectomy
* have one of the following diagnoses: personal history of sex reassignment, gender identity disorders, or transsexualism.

Cisgender Female Group

Inclusion:

- identified as female.

Exclusion:

* administered testosterone within 6 months and 1 day before their hysterectomy
* have one of the following diagnoses: personal history of sex reassignment, gender identity disorders, or transsexualism.

Orchiectomy Cohort:

Inclusion:

- patients underwent an orchiectomy.

Exclusion:

- history of malignant neoplasm of the testis, malignant neoplasm of the prostate, Fournier gangrene, or vascular disorders of male genital organs

Transgender Female Group

Inclusion:

* administered estrogen within 6 months and 1 day before their orchiectomy
* have one of the following diagnoses: personal history of sex reassignment, gender identity disorders, or transsexualism.

Cisgender Male Group

Inclusion:

- identified as male.

Exclusion:

* administered estrogen within 6 months and 1 day before their orchiectomy
* have one of the following diagnoses: personal history of sex reassignment, gender identity disorders, or transsexualism.

Augmentation Mammoplasty:

Inclusion:

- underwent augmentation mammoplasties.

Exclusion:

- Have diagnosis of malignant neoplasm of the breast .

Transgender Female Group

Inclusion:

* administered estrogen within 6 months and 1 day before their augmentation mammoplasty
* have one of the following diagnoses: personal history of sex reassignment, gender identity disorder, or transsexualism.

Cisgender Female Group

Inclusion:

- Identified as female

Exclusion:

* administered estrogen within 6 months and 1 day before their hysterectomy
* have one of the following diagnoses: personal history of sex reassignment, gender identity disorders, or transsexualism.

Primary outcomes:
measure: Rescue antiemetics
timeFrame: Within 24 hours of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Moreno Valley
country: United States
facility: Riverside University Health System Medical Center
state: California
Study officials:
References: