Exogenous Sex Hormones and PONV

Completed

• Conditions: Sex Hormone; Postoperative Nausea and Vomiting; Transgender

• Registration Number: NCT06816355
• Lead Sponsor: Riverside University Health System Medical Center

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.

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-04
• Primary Completion: 2025-02-04
• Study Completion: 2025-02-04
• Study First Submitted: 2025-02-04
• Study First Submitted QC: 2025-02-04
• Study First Posted: 2025-02-10
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7348

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rescue antiemetics	Within 24 hours of surgery	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.

Trial Locations

Locations (1)

Riverside University Health System Medical Center; 🇺🇸 Moreno Valley, California, United States