Clinical trial NCT05393583: In-hospital Versus DAy Care Hysterectomy in Transgender Men
Official title: In-hospital Versus DAy Care Hysterectomy in Transgender Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Outpatient Hysterectomy in Transmen
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 104
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-armed study

* arm 1: outpatient hysterectomy (discharge the day of the operation)
* arm 2: inpatient hysterectomy (1 night hospital stay)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Satisfaction with the length of hospital stay after 1 week assessed by the VAS (visual analogue scale)
timeFrame: Day 7
measure: Satisfaction with the length of hospital stay after 6 weeks assessed by the VAS (visual analogue scale)
timeFrame: Day 42
Secondary outcomes:
measure: Pain scores
timeFrame: Day 0 to 7
measure: Analgesics use
timeFrame: Day 0 to 7
measure: Type and number of intra-operative complications
timeFrame: Day 0
measure: Type and number of postoperative complications
timeFrame: Day 42
measure: Readmission rate
timeFrame: Day 42
measure: Postoperative quality of recovery (QoR)-15 score
timeFrame: Day 1, day 2 and day 42
measure: Postoperative wellbeing through the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Day 1, day 2 and day 42
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
References:
citation: 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.
citation: 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.