Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia
试验速览
- 阶段
- 4 期
- 入组人数
- 312
- 试验地点
- 2
- 主要终点
- Assess for reappearance of hiatal hernia and reflux
研究概览
简要总结
The investigators propose a randomized, single blinded controlled trial to compare the use of synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard of care surgical modalities. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.
详细描述
Patients will be randomized to either a synthetic (light weight synthetic or biologic (small intestinal submucosa ) mesh group. Endpoints will be measured up to 5 years for the study as a whole, at 6 months and at 60 months. Prior to and following laparoscopic paraesophageal hernia repair, patients will be followed with both subjective and objective measures. Subjective evaluation will include symptomatic/quality of life assessment at 1-, 6-, 24-, and 60- month periods; objective evaluation will include Upper GI study /pH probe study for symptomatic patients and for all patients at 6 and 60 months. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female gender
- •Age>18 years
- •Absence of chronic medical conditions that will affect the quality of life survey, such as fibromyalgia, SLE, Crohn's disease, etc.
- •Able to give informed consent
- •Able and willing to participate in follow-up evaluations
- •Upper GI with a documented hiatal hernia greater than 5cm
- •Paraesophageal hernia with clinically relevant symptoms such as heartburn, chest pain, regurgitation, dysphagia, postprandial abdominal pain, shortness of breath, or early satiety.
排除标准
- •Previous surgery of the esophagus and/or the stomach
- •Emergent operation for acute gastric volvulus or strangulation
- •Biopsy consistent with malignancy
- •Body Mass Index (BMI) over 35kg/m2
- •Inability to perform primary closure of crura
- •Active smoking
研究组 & 干预措施
Biodesign™ Surgisis® Graft, Cook Medical, Bloomington
Biologic mesh Biodesign™ Surgisis® Graft Reinforcement in Hiatal, Cook Medical, Bloomington, IN which will be placed for repair of hiatal hernia
干预措施: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington (Device)
Parietex™ Composite Hiatal Mesh, North Haven, CT
Synthetic prosthetic mesh Parietex™ Composite Hiatal (PCO 2H) Mesh (Covidien, North Haven, CT) designed for hiatal hernia repair.
干预措施: Parietex™ Composite Hiatal Mesh, North Haven, CT (Device)
Parietex™ Composite Hiatal Mesh, North Haven, CT
Synthetic prosthetic mesh Parietex™ Composite Hiatal (PCO 2H) Mesh (Covidien, North Haven, CT) designed for hiatal hernia repair.
干预措施: Biodesign™ Surgisis® Graft, Cook Medical, Bloomington (Device)
Biodesign™ Surgisis® Graft, Cook Medical, Bloomington
Biologic mesh Biodesign™ Surgisis® Graft Reinforcement in Hiatal, Cook Medical, Bloomington, IN which will be placed for repair of hiatal hernia
干预措施: Parietex™ Composite Hiatal Mesh, North Haven, CT (Device)
结局指标
主要结局
Assess for reappearance of hiatal hernia and reflux
时间窗: 6 months, 60 months
Change at 6 and 60 months will be assessed by pH and Upper GI (endoscopy) studies to assess for reappearance of hiatal hernia and reflux.
次要结局
- Quality of Life questionnaire(Quality of Life will be assessed at these time periods after the hernia repair 1, 6, 24, and 60 months)