In-hospital Versus DAy Care Hysterectomy in Transgender Men

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

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.

Official Title
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In-hospital Versus DAy Care Hysterectomy in Transgender Men

Conditions
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Outpatient Hysterectomy in Transmen

Intervention / Treatment
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* Procedure: Outpatient hysterectomy
* Procedure: Inpatient hysterectomy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2-armed study arm 1: outpatient hysterectomy (discharge the day of the operation) arm 2: inpatient hysterectomy (1 night hospital stay)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outpatient<br>Discharge on the day of hysterectomy | Procedure: Outpatient hysterectomy<br>* Discharge on the day of the hysterectomy<br>|
| Active Comparator: Inpatient<br>Discharge after 1 night stay in the hospital | Procedure: Inpatient hysterectomy<br>* 1 night hospital stay after hysterectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with the length of hospital stay after 1 week assessed by the VAS (visual analogue scale) | Satisfaction of the patient with the length of hospital stay 1 week after surgery assessed by a Visual Analogue Scale ranging from 0 to 100 (with 100 being extremely satisfied) | Day 7 | 
| Satisfaction with the length of hospital stay after 6 weeks assessed by the VAS (visual analogue scale) | Satisfaction of the patient with the length of hospital stay 6 weeks after surgery assessed by a Visual Analogue Scale ranging from 0 to 100 (with 100 being extremely satisfied) | Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | Pain will be measured by using a Visual Analogue Scale for pain ranging from 0 to 10 (with 10 being the worst pain ever) | Day 0 to 7 | 
| Analgesics use | The amount of analgesics used every day | Day 0 to 7 | 
| Type and number of intra-operative complications |  | Day 0 | 
| Type and number of postoperative complications |  | Day 42 | 
| Readmission rate |  | Day 42 | 
| Postoperative quality of recovery (QoR)-15 score | The QoR-15 is a patient-reported outcome questionnaire that measures the quality of recovery after surgery and anaesthesia. Each question is scored from 0 (= none of the time) to 10 (= all of the time) for positive items; for negative items the scoring is reversed (maximum score 150). | Day 1, day 2 and day 42 | 
| Postoperative wellbeing through the Hospital Anxiety and Depression Scale (HADS) | Postoperative wellbeing will be assessed by using the HADS. The HADS is a 14-question instrument that measures anxiety and depression. Each question is scored between 0 (no impairment) and 3 (severe impairment), with a maximum score of 21 for anxiety or depression. | Day 1, day 2 and day 42 |