Exogenous Sex Hormones and PONV

NCT ID: NCT06816355

Last Updated: 2025-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7348 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-04

Study Completion Date

2025-02-04

Brief Summary

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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

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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.

Conditions

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Postoperative Nausea and Vomiting Sex Hormone Transgender

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Transgender male

Hysterectomy

Intervention Type PROCEDURE

CPT:1013911

Transgender female

Orchiectomy

Intervention Type PROCEDURE

CPT:54520

Augmentation mammoplasty

Intervention Type PROCEDURE

CPT:19325

Cisgender male

Orchiectomy

Intervention Type PROCEDURE

CPT:54520

Cisgender female

Hysterectomy

Intervention Type PROCEDURE

CPT:1013911

Augmentation mammoplasty

Intervention Type PROCEDURE

CPT:19325

Interventions

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Orchiectomy

CPT:54520

Intervention Type PROCEDURE

Hysterectomy

CPT:1013911

Intervention Type PROCEDURE

Augmentation mammoplasty

CPT:19325

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\- 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riverside University Health System Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Christopher Baker

Research Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Riverside University Health System Medical Center

Moreno Valley, California, United States

Site Status

Countries

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United States

Other Identifiers

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PONV

Identifier Type: -

Identifier Source: org_study_id

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