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Completed

NCT Number: NCT06816355

Exogenous Sex Hormones and PONV

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Riverside University Health System Medical Center

Moreno Valley, California, 92555, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orchiectomy

Procedure

CPT:54520

Hysterectomy

Procedure

CPT:1013911

Augmentation mammoplasty

Procedure

CPT:19325

Primary outcomes

  1. Rescue antiemetics

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Riverside University Health System Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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