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Exogenous Sex Hormones and PONV

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06816355
Enrollment
7348
Registered
2025-02-10
Start date
2025-02-04
Completion date
2025-02-04
Last updated
2025-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting, Sex Hormone, Transgender

Keywords

Postoperative nausea and vomiting, sex hormone, estrogen, testosterone, transgender

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.

Interventions

PROCEDUREOrchiectomy

CPT:54520

PROCEDUREHysterectomy

CPT:1013911

PROCEDUREAugmentation mammoplasty

CPT:19325

Sponsors

Riverside University Health System Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Rescue antiemeticsWithin 24 hours of surgeryThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026