A Randomized Study Comparing Four Different Postoperative Follow-up Strategies for Improved Postoperative Recovery After Benign Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 525
- 试验地点
- 10
- 主要终点
- Quality of life as measured by the EQ-5D health index
研究概览
简要总结
The purpose of the study is to investigate the effect of four different follow-up strategies on postoperative recovery following vaginal or abdominal hysterectomy for benign conditions. Furthermore the investigators aim to examine associations between preoperative thresholds for pain (thermal and pressure) and postoperative pain and development of chronic pelvic pain after benign hysterectomy.
详细描述
Contact sponsor if detailed information is requested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 18 and 60 years of age.
- •Women who are scheduled for vaginal or abdominal total or subtotal hysterectomy for benign gynecological diseases (including cervical dysplasia).
- •Women who understand and speak Swedish fluently.
- •Women who gives signed informed consent to participate in the study.
- •Women who have access to a telephone and/or internet.
排除标准
- •Women where the hysterectomy is carried out in association with surgery for genital prolapse
- •Women with genital malignancies (does not include cervical dysplasia).
- •Women where the operation is planned or expected to comprise more than the hysterectomy with or without unilateral salpingooophorectomy and appendectomy en passant.
- •Women with previous bilateral salpingooophorectomy.
- •Women who are physically disabled to a degree so that mobilization postoperatively cannot be expected as for a normal individual.
- •Women who are mentally disabled to a degree so she cannot complete the forms in the study or understand the tenor of the participation or it is considered doubtful from an ethical point of view to participate.
- •Women with psychiatric disease or is on medication for severe psychiatric disease so that the physician consider participation in the study unsuitable.
- •Women with current drug or alcohol abuse.
结局指标
主要结局
Quality of life as measured by the EQ-5D health index
时间窗: Six weeks
The Euroqol questionnaire form (EQ-5D) are used for assessing the quality of life. Assessments preoperatively, once daily the first week postoperatively and then once weekly for additional five weeks.
Quality of life as measured by the SF-36 sub scale scores
时间窗: Six weeks
The Short-Form 36 (SF-36) are used for assessing the quality of life. Assessments preoperatively, and after six weeks
次要结局
- Complications related to operation(Six weeks)
- Health economy(Up to 1 years)
- Consumption of analgesic(Six weeks)
- Duration of sick-leave(Up to one year)
- Postoperative symptoms(Six weeks)
- Development of chronic pelvic pain(One year)
研究者
Preben Kjolhede, MD, professor
Professor
University Hospital, Linkoeping