In-hospital Versus DAy Care Hysterectomy in Transgender Men (IDAH)

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

Study Overview

• Status: Completed
• Conditions: Outpatient Hysterectomy in Transmen
• Intervention / Treatment: Procedure: Outpatient hysterectomy; Procedure: Inpatient hysterectomy

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium
    • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Outpatient; Discharge on the day of hysterectomy	Procedure: Outpatient hysterectomy; Discharge on the day of the hysterectomy
Active Comparator: Inpatient; Discharge after 1 night stay in the hospital	Procedure: Inpatient hysterectomy; 1 night hospital stay after hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2019
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EC/2018/1387

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No