Outpatient Hysterectomy in TransmenIDAHNCT05393583
In-hospital Versus DAy Care Hysterectomy in Transgender Men
A study testing Outpatient hysterectomy and Inpatient hysterectomy in people with Outpatient Hysterectomy in Transmen, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
In this trial 2 groups of transmen who are getting a hysterectomy will be compared: inpatient vs outpatient. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Outpatient Hysterectomy in Transmen
- What is being tested?
- Outpatient hysterectomy and Inpatient hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Jan 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- transgender man
- 18y or older
- registers for a total hysterectomy at the genderclinic of UZ Gent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
In this trial 2 groups of transmen who are getting a hysterectomy will be compared: inpatient vs outpatient.
Read the 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.
- Conditions
- Outpatient Hysterectomy in Transmen
- Being tested
- Outpatient hysterectomy, Inpatient hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient hysterectomyProcedure or surgery
Discharge on the day of the hysterectomy
Inpatient hysterectomyProcedure or surgery
1 night hospital stay after hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Outpatient | Experimental | Discharge on the day of hysterectomy Receives: Procedure: Outpatient hysterectomy |
| Inpatient | Active comparator | Discharge after 1 night stay in the hospital Receives: Procedure: Inpatient hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Day 42
Secondary outcomes (7)
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)
Measured: Day 0 to 7
Analgesics use
The amount of analgesics used every day
Measured: Day 0 to 7
Type and number of intra-operative complications
Measured: Day 0
Type and number of postoperative complications
Measured: Day 42
Readmission rate
Measured: 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).
Measured: 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.
Measured: Day 1, day 2 and day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start25 Jan 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Outpatient Hysterectomy in TransmenStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393583
- Sponsor's protocol ID
- EC/2018/1387
- Acronym
- IDAH
- Status last verified
- Jan 2024
- First submitted
- 21 Jan 2022
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28810192Kisic-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.
PubMed 21272844Verberckmoes 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.
PubMed 40856135
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-hospital Versus DAy Care Hysterectomy in Transgender Men
- ClinicalTrials.gov ID
- NCT05393583
- Acronym / sponsor ID
- IDAH / EC/2018/1387
- Conditions
- Outpatient Hysterectomy in Transmen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2-armed study * arm 1: outpatient hysterectomy (discharge the day of the operation) * arm 2: inpatient hysterectomy (1 night hospital stay)
| Arm | Type | Receives |
|---|---|---|
| Outpatient | Experimental | Procedure: Outpatient hysterectomyDischarge on the day of hysterectomy |
| Inpatient | Active comparator | Procedure: Inpatient hysterectomyDischarge after 1 night stay in the hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- transgender man
- 18y or older
- registers for a total hysterectomy at the genderclinic of UZ Gent.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient hysterectomyDischarge on the day of the hysterectomy | Procedure or surgery | Outpatient |
| Inpatient hysterectomy1 night hospital stay after hysterectomy | Procedure or surgery | Inpatient |
Primary outcome
Satisfaction with the length of hospital stay after 1 week assessed by the VAS (visual analogue scale)
Time frame: 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)
Time frame: 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)
7 secondary outcomes
Pain scores
Time frame: Day 0 to 7
Analgesics use
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
Time frame: Day 1, day 2 and day 42
Postoperative wellbeing through the Hospital Anxiety and Depression Scale (HADS)
Time frame: Day 1, day 2 and day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Background: PubMed 28810192Dedden 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.
- Background: PubMed 21272844Kisic-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.
- Derived from this study: PubMed 40856135Verberckmoes 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient hysterectomy and Inpatient hysterectomy in people with Outpatient Hysterectomy in Transmen, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with the length of hospital stay after 1 week assessed by the VAS (visual analogue scale) (time frame: Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05393583, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.