Laparoscopic Hysterectomy - A Randomized Controlled Trial on Outpatient Versus Inpatient Regimen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 主要终点
- Patient satisfaction and quality of life
研究概览
简要总结
Laparoscopic Hysterectomy (LH) is increasingly used as a standard surgical approach to hysterectomy. It is a safe procedure with low rates of complications and readmissions. Increasing evidence indicates that LH may be suitable for an outpatient setting but this may impair patient's satisfaction in more than 25% of cases. In addition, change from in-patient care to day case surgery might influence readmission rates and postoperative physical activity. No data are available on the current length of sick leave in Danish patients after hysterectomy, and the effects of outpatient surgery on this parameter are difficult to predict. A randomized controlled trial of LH performed as an outpatient procedure compared with today's inpatient standard will provide a firm platform for future planning of routine treatment of patients with need of hysterectomy for benign indications.
详细描述
Hysterectomy is the most frequent gynecological operation world wide and the indication is often benign. The women are healthy and young with a median age below 50 years. In Denmark, hysterectomy is performed as an inpatient procedure with a median hospitalization of 1 day. Hysterectomies in Denmark are distributed by 45% abdominal hysterectomies (AH), 35% vaginal hysterectomies (VH) and 20% laparoscopic hysterectomies (LH). There is no final consensus whether VH or LH should be recommended as first choice but LH is gaining more and more acceptance. Increasing evidence indicates that LH may be suitable for an outpatient setting. Data seem to assure that outpatient LH is feasible but patient's satisfaction in this setting remains an open question. A detailed analysis of data from a Norwegian study indicates that patients reporting dissatisfaction with the early discharge amounts to 25-38%. Such a decrease in patient's satisfaction would present a significant problem, and a randomized controlled study of sufficient size with focus on this aspect is therefore needed.
Recommendations on postoperative sick leave vary considerably, due to lack of evidence-based guidelines and no firm data are available on the relation between outpatient treatment and sick leave in gynecology.
This randomized controlled study attempt to examine outpatient LH and patient satisfaction and related subject as readmissions and complications, time to return to work, physical activity in the recuperation period and an overall socioeconomic calculation of the costs of LH in an in- and outpatient setting.
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
入排标准
- 年龄范围
- 18 Years 至 56 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal women below 56 years who is in need of a hysterectomy for benign conditions.
- •Additional surgery is allowed in the gynecological area.
- •BMI and working status is NOT exclusion criteria's.
排除标准
- •Unable to read and write Danish to answer questionnaires.
- •Unable to walk to carry a pedometer.
结局指标
主要结局
Patient satisfaction and quality of life
时间窗: 4 weeks from date of surgery
The difference in patient satisfaction between inpatient and outpatient laparoscopic hysterectomy 4 weeks from surgery measured by the European Quality of life questionnaire in 5 dimensions (EQ5D) and presented as an index number.
Satisfaction with length of stay after total laparoscopic hysterectomy.
时间窗: 2 weeks after surgery
Difference in satisfaction with length of stay between intervention group and placebo measured on a visual analogue scale from 0 to 10 with 10 being most satisfied and presented on an international unit scale.
次要结局
- Incidence and pattern of complications and readmissions for in- and outpatient LH.(4 weeks from the date of surgery)
- Physical activity in the recovery period after in- and outpatient LH.(4 weeks from the date of surgery)
- Return to work after in- and outpatient LH.(6 month from the date of surgery)