In-hospital Versus DAy Care Hysterectomy in Transgender Men

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

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-25

Study Completion Date

2023-12-31

Brief Summary

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In this trial 2 groups of transmen who are getting a hysterectomy will be compared: inpatient vs outpatient.

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Detailed Description

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In this trial transmen who consultate for a hysterectomy are randomised over 2 groups: inpatient vs outpatient.

In the inpatient group the participant stays 1 night in the hospital after the laparoscopic hysterectomy. The outpatient group can leave the hospital the day of the operation. Standard care after laparoscopic hysterectomy is 2 nights hospital stay.

Through this trial the investigators would like to answer following questions:

* Is hysterectomy in dayclinic as safe as a hysterectomy in an outpatient setting?
* Is there a higher complication/re-admission rate with hysterectomy in outpatient setting?
* Are patients as satisfied with the length of hospital stay in an inpatient hysterectomy?
* Is the need for pain medication higher in the inpatient group? Do this patients experience more postoperative pain?
* Is there a loss in 'quality of life' with hysterectomy in inpatient setting?
* Are patients who have the hysterectomy in dayclinic more anxious/worried?

The primary objective is the satisfaction of the patient with the length of hospital stay. The other indicators will be seen as secondary outcomes.

Conditions

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Outpatient Hysterectomy in Transmen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2-armed study

* arm 1: outpatient hysterectomy (discharge the day of the operation)
* arm 2: inpatient hysterectomy (1 night hospital stay)

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Blinding not possible

Study Groups

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Outpatient

Discharge on the day of hysterectomy

Group Type EXPERIMENTAL

Outpatient hysterectomy

Intervention Type PROCEDURE

Discharge on the day of the hysterectomy

Inpatient

Discharge after 1 night stay in the hospital

Group Type ACTIVE_COMPARATOR

Inpatient hysterectomy

Intervention Type PROCEDURE

1 night hospital stay after hysterectomy

Interventions

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Outpatient hysterectomy

Discharge on the day of the hysterectomy

Intervention Type PROCEDURE

Inpatient hysterectomy

1 night hospital stay after hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* transgender man
* 18y or older
* registers for a total hysterectomy at the genderclinic of UZ Gent.

Exclusion Criteria

* simultaneous planned breast surgery/scar corrections
* ASA score 3-4
* persons with mental retardation or severe psychiatric disorder
* persons without an adult caretaker / partner present the first night after discharge from the hospital

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes