In-hospital Versus DAy Care Hysterectomy in Transgender Men (IDAH)

Ghent University Hospital (UZ)

Status: Completed

Conditions: Outpatient Hysterectomy in Transmen

Treatments: Procedure: Outpatient hysterectomy; Procedure: Inpatient hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05393583

EC/2018/1387

Details and patient eligibility

About

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

Full description

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.

Enrollment: 104 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Outpatient

Experimental group

Description:

Discharge on the day of hysterectomy

Treatment:

Procedure: Outpatient hysterectomy

Inpatient

Active Comparator group

Description:

Discharge after 1 night stay in the hospital

Treatment:

Procedure: Inpatient hysterectomy