In-hospital Versus DAy Care Hysterectomy in Transgender Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Satisfaction with the length of hospital stay after 1 week assessed by the VAS (visual analogue scale)
研究概览
简要总结
In this trial 2 groups of transmen who are getting a hysterectomy will be compared: inpatient vs outpatient.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Blinding not possible
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •transgender man
- •18y or older
- •registers for a total hysterectomy at the genderclinic of UZ Gent.
排除标准
- •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
结局指标
主要结局
Satisfaction with the length of hospital stay after 1 week assessed by the VAS (visual analogue scale)
时间窗: 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)
时间窗: 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)
次要结局
- Pain scores(Day 0 to 7)
- Type and number of intra-operative complications(Day 0)
- Analgesics use(Day 0 to 7)
- Readmission rate(Day 42)
- Type and number of postoperative complications(Day 42)
- Postoperative quality of recovery (QoR)-15 score(Day 1, day 2 and day 42)
- Postoperative wellbeing through the Hospital Anxiety and Depression Scale (HADS)(Day 1, day 2 and day 42)