NCT01526655已完成不适用
A Randomized Open Controlled Trial Comparing Robot Assisted Laparoscopic Hysterectomy and Abdominal Hysterectomy for Endometrial Cancer in a Fast Track Program
University Hospital, Linkoeping4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年1月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Health Related Quality of Life (HRQoL)
研究概览
简要总结
The purpose of the trial is to determine whether robot assisted laparoscopic hysterectomy compared with abdominal hysterectomy in a fast track program gives a faster recovery postoperatively, causes less tissue damage and less effects on the immunological system, and is health economically cost-effective.
详细描述
If detailed description is requested, please contact sponsor.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age.
- •Scheduled to total hysterectomy + bilateral salpingooophorectomy (BSAE) and peritoneal lavage because of endometrial carcinoma, International federation of gynecology and obstetrics (FIGO) stage 1, grade 1 and 2, with diploid DNA profile (i.e. low risk profile).
- •WHO (World Health Organisation) performance status ≤
- •Proficiency in Swedish
- •Accept to participate in the study and has signed written informed consent document.
- •The operation should be considered possible to be perform laparoscopically and by laparotomy through a low transverse abdominal wall incision.
排除标准
- •The operation is anticipated to comprise more than the hysterectomy + BSAE.
- •A midline incision is planned for the laparotomy.
- •Contraindications towards spinal anesthesia with intrathecally applied morphine.
- •Physically disabled women who cannot be expected to be mobilized in accordance to the fast track program in a way similar to what is expected from not-physically disabled women.
- •Mentally disabled women who cannot fill in the questionnaires or understand the consequences of participating in a trial.
- •Severe psychiatric disease or on medication for psychiatric disease so that the physician consider participation in the trial inappropriate.
结局指标
主要结局
Health Related Quality of Life (HRQoL)
时间窗: Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35, 42
Quality of life measured by means of the EuroQol form (EQ-5D). The EQ-5D form was completed daily during the first eight days after surgery, then once weekly for additional six weeks. The health state index has a possible range from 0 to 1 with a higher score meaning a better quality of life.
次要结局
- Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP))(One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.)
- Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK))(One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.)
- Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC))(One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.)
- Health Economics (With 300 Robotic Procedures Annually)(From the day of surgery until six weeks after surgery.)
- Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6))(One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.)
- Changes in Biomarkers for Tissue Damage (Cortisol)(One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.)
- Health Economics (With 500 Robotic Procedures Annually)(From the day of surgery until six weeks after surgery.)
研究者
Preben Kjolhede, MD, professor
Professor
University Hospital, Linkoeping
研究点 (4)
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