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In this trial 2 groups of transmen who are getting a hysterectomy will be compared: inpatient vs outpatient.
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:
The primary objective is the satisfaction of the patient with the length of hospital stay. The other indicators will be seen as secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatient | Experimental | Discharge on the day of hysterectomy |
|
| Inpatient | Active Comparator | Discharge after 1 night stay in the hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Outpatient hysterectomy | Procedure | Discharge on the day of the hysterectomy |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
transmen
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28810192 | Background | Dedden SJ, Geomini PMAJ, Huirne JAF, Bongers MY. Vaginal and Laparoscopic hysterectomy as an outpatient procedure: A systematic review. Eur J Obstet Gynecol Reprod Biol. 2017 Sep;216:212-223. doi: 10.1016/j.ejogrb.2017.07.015. Epub 2017 Jul 22. | |
| 21272844 | Background | Kisic-Trope J, Qvigstad E, Ballard K. A randomized trial of day-case vs inpatient laparoscopic supracervical hysterectomy. Am J Obstet Gynecol. 2011 Apr;204(4):307.e1-8. doi: 10.1016/j.ajog.2010.11.014. Epub 2011 Jan 26. |
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2-armed study
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Blinding not possible
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| Inpatient hysterectomy |
| Procedure |
1 night hospital stay after hysterectomy |
|
| 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 |
| 40856135 | Derived | Verberckmoes B, van Wessel S, Hamerlynck T, Bosteels J, Coppens M, Weyers S. Ambulatory Versus Inpatient Total Laparoscopic Hysterectomy in Trans Men: A Randomised Controlled Non-Inferiority Trial. BJOG. 2026 Jan;133(1):52-60. doi: 10.1111/1471-0528.18340. Epub 2025 Aug 26. |