Exogenous Sex Hormones and PONV

Exogenous Sex Hormones and PONV: Evaluating Postoperative Nausea and Vomiting Risk in Transgender Patients

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).

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting; Transgender; Sex Hormone
• Intervention / Treatment: Procedure: Hysterectomy; Procedure: Orchiectomy; Procedure: 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.

• Study Type: Observational
• Enrollment (Actual): 7348

Contacts and Locations

Study Locations

• United States
  • California
    • Moreno Valley, California, United States, 92555
      • Riverside University Health System Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing orchiectomies, hysterectomies, or augmentation mammoplasties.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transgender male	Procedure: Hysterectomy; CPT:1013911
Transgender female	Procedure: Orchiectomy; CPT:54520; Procedure: Augmentation mammoplasty; CPT:19325
Cisgender male	Procedure: Orchiectomy; CPT:54520
Cisgender female	Procedure: Hysterectomy; CPT:1013911; Procedure: Augmentation mammoplasty; CPT:19325

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rescue antiemetics	The primary outcome will be the administration of a rescue antiemetic within 24 hours of surgery. Rescue antiemetics will include droperidol, promethazine, dimenhydrinate, metoclopramide, and prochlorperazine based on rescue antiemetics from the Fourth Consensus PONV Guidelines.	Within 24 hours of surgery

Collaborators and Investigators

• Sponsor: Riverside University Health System Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2025
• Primary Completion (Actual): February 4, 2025
• Study Completion (Actual): February 4, 2025

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: estrogen; transgender; Postoperative nausea and vomiting; testosterone; sex hormone
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: PONV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: A plan to share IPD is not in place at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No