In-hospital Versus DAy Care Hysterectomy in Transgender Men
- Conditions
- Outpatient Hysterectomy in Transmen
- Interventions
- Procedure: Outpatient hysterectomyProcedure: Inpatient hysterectomy
- Registration Number
- NCT05393583
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
In this trial 2 groups of transmen who are getting a hysterectomy will be compared: inpatient vs outpatient.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 104
- transgender man
- 18y or older
- registers for a total hysterectomy at the genderclinic of UZ Gent.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Outpatient Outpatient hysterectomy Discharge on the day of hysterectomy Inpatient Inpatient hysterectomy Discharge after 1 night stay in the hospital
- Primary Outcome Measures
Name Time Method Satisfaction with the length of hospital stay after 1 week assessed by the VAS (visual analogue scale) Day 7 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)
Satisfaction with the length of hospital stay after 6 weeks assessed by the VAS (visual analogue scale) Day 42 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)
- Secondary Outcome Measures
Name Time Method Pain scores Day 0 to 7 Pain will be measured by using a Visual Analogue Scale for pain ranging from 0 to 10 (with 10 being the worst pain ever)
Type and number of intra-operative complications Day 0 Analgesics use Day 0 to 7 The amount of analgesics used every day
Readmission rate Day 42 Type and number of postoperative complications Day 42 Postoperative quality of recovery (QoR)-15 score Day 1, day 2 and day 42 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).
Postoperative wellbeing through the Hospital Anxiety and Depression Scale (HADS) Day 1, day 2 and day 42 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.
Trial Locations
- Locations (1)
University Hospital Ghent
🇧🇪Ghent, Belgium