ISRCTN76437720进行中（未招募）未知
A randomised controlled feasibility trial of a novel polyvinylideneflouride (PVDF) mesh (DYNAMesh-hIatus) Cruroplasty versus suture only repair of large hiatus hernia
Portsmouth Hospital NHS Trust0 个研究点目标入组 40 人开始时间: 2018年11月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. NHS patients undergoing:
- •1.1. Elective laparoscopic repair of large hiatus hernia (>5 cm in size)
- •1.2. Fundoplication for gastro-oesophageal reflux disease
- •2. Fulfil criteria for keyhole surgery
- •3. Aged 18 years or older
- •4. Body mass index <40 kg/m²
- •5. Able to provide written informed consent
排除标准
- •1. Concomitant medical condition likely to shorten survival to less than 1 year
- •2. Previous hiatus hernia surgery
- •3. Active treatment for any cancer
- •4. Pregnancy
- •5. Contraindications to MRI for supplementary MRI study (can still be recruited into the study, but not for the MRI study at 1 year), including:
- •5.1. Any metal implants
- •5.2. Pacemaker
- •5.3. Reveal devices
研究者
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