NCT06816355

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,348

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 4, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

Same day

First QC Date

February 4, 2025

Last Update Submit

February 19, 2025

Conditions

Postoperative Nausea and VomitingSex HormoneTransgender

Keywords

Postoperative nausea and vomitingsex hormoneestrogentestosteronetransgender

Outcome Measures

Primary Outcomes (1)

  • Rescue antiemetics

    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.

    Within 24 hours of surgery

Study Arms (4)

Transgender male

Procedure: Hysterectomy

Transgender female

Procedure: OrchiectomyProcedure: Augmentation mammoplasty

Cisgender male

Procedure: Orchiectomy

Cisgender female

Procedure: HysterectomyProcedure: Augmentation mammoplasty

Interventions

OrchiectomyPROCEDURE

CPT:54520

Cisgender maleTransgender female
HysterectomyPROCEDURE

CPT:1013911

Cisgender femaleTransgender male
Augmentation mammoplastyPROCEDURE

CPT:19325

Cisgender femaleTransgender female

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsCisgender males, Cisgender females, Transgender males, Transgender females
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing orchiectomies, hysterectomies, or augmentation mammoplasties.

You may qualify if:

  • \- Patients who underwent hysterectomies.

You may not qualify if:

  • \- Patients who had malignant neoplasm of the uterus, ovarian, cervical, endometrium, or adnexa.
  • Transgender Male Group
  • 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
  • \- identified as female.
  • 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:
  • \- patients underwent an orchiectomy.
  • \- history of malignant neoplasm of the testis, malignant neoplasm of the prostate, Fournier gangrene, or vascular disorders of male genital organs
  • Transgender Female Group
  • 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riverside University Health System Medical Center

Moreno Valley, California, 92555, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

OrchiectomyHysterectomy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

CastrationEndocrine Surgical ProceduresSurgical Procedures, OperativeUrogenital Surgical ProceduresUrologic Surgical Procedures, MaleUrologic Surgical ProceduresGynecologic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Coordinator

Study Record Dates

First Submitted

February 4, 2025

First Posted

February 10, 2025

Study Start

February 4, 2025

Primary Completion

February 4, 2025

Study Completion

February 4, 2025

Last Updated

February 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

A plan to share IPD is not in place at this time.

Locations

US(1)