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Exogenous Sex Hormones and PONV

R

Riverside University Health System Medical Center

Status

Completed

Conditions

Sex Hormone
Transgender
Postoperative Nausea and Vomiting

Treatments

Procedure: Hysterectomy
Procedure: Augmentation mammoplasty
Procedure: Orchiectomy

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Full 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.

Enrollment

7,348 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

7,348 participants in 4 patient groups

Transgender male
Treatment:
Procedure: Hysterectomy
Transgender female
Treatment:
Procedure: Orchiectomy
Procedure: Augmentation mammoplasty
Cisgender male
Treatment:
Procedure: Orchiectomy
Cisgender female
Treatment:
Procedure: Augmentation mammoplasty
Procedure: Hysterectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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