A Multinational Randomized Controlled Trial Including Two Identical Sub Studies Comparing Vaginal Versus vNOTES (Vaginal Natural Orifice Transluminal Surgery) Hysterectomy or Laparoscopic Versus vNOTES Hysterectomy.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- proportion of women leaving the hospital within 12 hours after surgery complications.
研究概览
简要总结
A randomized controlled trial comparing the vaginal, vNOTES ( vaginal natural orifice transluminal surgery) or laparoscopic approach for hysterectomy in women with benign gynaecological disease
详细描述
Multi-center pragmatic non-blinded RCT including 1000 women 18-75 years in need of hysterectomy for benign disease; comparing VH vs vNOTES or LH vs vNOTES.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 75 years regardless of parity with benign indication for hysterectomy
排除标准
- •Women with a stage II+ prolapse in need of a hysterectomy as part of vaginal prolapse repair
- •hysterectomy due to suspected endometriosis
- •subtotal hysterectomy
- •history of rectal surgery
- •suspected malignancy
- •suspected obliteration of the pouch of Douglas following severe PID or other causes
- •active lower genital tract infection
- •pregnancy
- •failure to provide written informed consent prior to surgery
- •requirement of in-patient care due to other co-morbidities
研究组 & 干预措施
vNOTES vs Vaginal Hysterectomy
Group A: If VH is concidered safe and feasable; the patient is randomized between VH and vNOTES
干预措施: vNOTES vs Vaginal Hysterectomy (Procedure)
vNOTES vs Laparoscopic Hysterectomy
If VH is not concidered safe and feasable; The patient is randomized between LH and vNOTES
干预措施: vNOTES vs Laparoscopic Hysterectomy (Procedure)
结局指标
主要结局
proportion of women leaving the hospital within 12 hours after surgery complications.
时间窗: 12 hours
Day sugery
次要结局
- Patient Reported Outcome Measures.(3 months postop)
- conversion rates(12 hours)
- re-admission requiring hospitalization(6 weeks)
- duration of the surgical procedure(12 hours)
- Hospitalization time(6 weeks)
- postoperative complications,(6 weeks)
- Intraoperative complications.(12 hours)
研究者
Dr Jan Baekelandt, MD
Prof
Imelda Hospital, Bonheiden