An interventional study of Outpatient hysterectomy and Inpatient hysterectomy in Outpatient Hysterectomy in Transmen, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-08.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Health services research
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.
University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Discharge on the day of hysterectomy
Procedure: Outpatient hysterectomy
Discharge after 1 night stay in the hospital
Procedure: Inpatient hysterectomy
Discharge on the day of the hysterectomy
1 night hospital stay after hysterectomy
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)
Time frame: 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)
Time frame: Day 42
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)
Time frame: Day 0 to 7
Analgesics use
The amount of analgesics used every day
Time frame: Day 0 to 7
Type and number of intra-operative complications
Time frame: Day 0
Type and number of postoperative complications
Time frame: Day 42
Readmission rate
Time frame: 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).
Time frame: 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.
Time frame: Day 1, day 2 and day 42
Plan to share: No
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Ghent