A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias With Sutures Versus Pledgeted Sutures Versus Absorbable Mesh
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 165
- 主要终点
- Hiatal hernia recurrence rate
研究概览
简要总结
A prospective randomised multi - center trial on the repair of large hiatal hernias with sutures versus pledgeted sutures versus absorbable mesh
The primary objective of the present trial is to compare the hiatal hernia recurrence rate between three different methods of cruroplasty in large hiatal hernias: hiatal closure with sutures versus pledgeted sutures versus absorbable mesh (Phasix™ST mesh).
The duration of the study is not limited and depends on the number of cases planned. After enrollment in the study, patients will be followed - up with standardized questionnaires and gastroscopy at 6 months, 1 year, 3 years and 5 years after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a large hiatal hernia - admitted for surgery (laparoscopic / robot-assisted)
- •Written informed consent
- •≥ 18 years of age
- •Hiatal hernia documented by barium x-ray and/or gastroscopy and/or manometry by one or more of the following criteria:
- •> 5cm hiatal hernia
- •1/3 of the stomach in the thorax
排除标准
- •Lack of patient consent for study participation
- •Lack of consent to study due to linguistic or mental incomprehension
- •Patients in poor general condition (lack of anesthesia ability)
- •Pregnancy
- •Prior surgery on the stomach or gastroesophageal junction
- •Simultaneous surgery because of another illness
结局指标
主要结局
Hiatal hernia recurrence rate
时间窗: 6 months, 1 year, 3 years and 5 years after surgery
Hiatal hernia recurrence rate documented by gastroscopy
次要结局
- Symptoms related to Gastroesophageal Reflux Disease (GERD)(Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery)
- Postoperative complications(6 months, 1 year, 3 years and 5 years after surgery)
- Predictive parameters for treatment response or failure I(Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery)
- Quality of Life evaluated by questionnaire(Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery)
- Primary extraesophageal GERD symptoms related to Gastroesophageal Reflux Disease (GERD)(Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery)
- Length of hospital stay(up to 90 days)
- Predictive parameters for treatment response or failure II(Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery)
研究者
Michael Weitzendorfer, MD
Dr. Michael Weitzendorfer, PhD
Paracelsus Medical University