Use of Strattice in the Laparoscopic Suture Closure of a Paraesophageal Hernia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Hernia recurrence
研究概览
简要总结
The objective of this study is to examine the safety and efficacy of porcine acellular dermal matrix mesh (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of laparoscopic large paraesophageal hernia repair.
详细描述
Prosthetic reinforcements reduce recurrence rates; the choice of optimal prosthetic, either synthetic or biosynthetic, for crural reinforcement is controversial. The objective of this study is to examine the safety and efficacy of porcine acellular dermal matrix mesh (Strattice; LifeCell Corp., Branchburg, NJ) in crural reinforcement of laparoscopic large paraesophageal hernia repair. Strattice is a commonly used mesh in hernia repair. 35 adult (>19 years of age) patients will be selected based on inclusion and exclusion criteria. Patients who meet the criteria will be enrolled in the study. Information related to recurrence rates based on follow-up visits will be analyzed to determine the efficacy of Strattice in the prevention of large hernia recurrence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented symptomatic paraesophageal hernia.
- •Greater than 5 cm hiatal hernia on upper gastrointestinal study.
- •Evidence that the stomach or other viscera is present in the hernia and does not spontaneously reduce from the mediastinum.
- •Significant symptoms or signs of a paraesophageal hernia including but not limited to heartburn, dysphagia, chest pain, shortness of breath, postprandial abdominal pain, early satiety, odynophagia, or chronic anemia.
- •Consenting adult 19 years of age or older
- •Must be able to participate in follow-up evaluation.
- •Free of cognitive impairment
排除标准
- •Children and adolescents (19 years of age or younger).
- •Pregnant and breast feeding patients.
- •Vulnerable subjects such as pregnant women, children less than 19 years age, and decisionally impaired persons.
- •Patients with previous operation of the esophagus or stomach.
- •Patients with associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of life assessment (e.g. Crohn's disease).
- •Patients with emergent operation for acute gastric volvulus.
- •Patients with known sensitivity to porcine material.
结局指标
主要结局
Hernia recurrence
时间窗: 1 year post-surgery
A barium swallow test with x-rays will be performed to assess recurrence of hernia, if any
次要结局
- Recurrence of reflux symptoms(2 weeks, 6 months and 1 year post-surgery)