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Completed

NCT Number: NCT05393583

In-hospital Versus DAy Care Hysterectomy in Transgender Men

In this trial 2 groups of transmen who are getting a hysterectomy will be compared: inpatient vs outpatient.

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Key information

Conditions

Outpatient Hysterectomy in Transmen

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Outpatient hysterectomy

Procedure

Discharge on the day of the hysterectomy

Inpatient hysterectomy

Procedure

1 night hospital stay after hysterectomy

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Pain scores

    Time frame: 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)

  2. Analgesics use

    Time frame: Day 0 to 7

    The amount of analgesics used every day

  3. Type and number of intra-operative complications

    Time frame: Day 0

  4. Type and number of postoperative complications

    Time frame: Day 42

  5. Readmission rate

    Time frame: Day 42

  6. Postoperative quality of recovery (QoR)-15 score

    Time frame: 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).

  7. Postoperative wellbeing through the Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Acronym: IDAH

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 26, 2022
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.