A Randomized, Blinded, Parallel-group Trial Evaluating Mesh Versus Pledgeted Sutures in Paraesophageal Hernia Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- David Krpata
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Radiographic recurrence rate
研究概览
简要总结
The goal of this clinical trial is to compare whether the use of Ovitex mesh provides superior reduction in 2-year recurrence compared to pledgeted suture closure (no mesh) for patients undergoing paraesophageal hernia repair at the Cleveland Clinic. The main questions it aims to answer are:
- Determine whether there is a difference in 2-year rates of radiographic recurrence with Ovitex versus pledgeted sutures in paraesophageal hernia repair.
- Assess patient quality of life (QOL) after paraesophageal hernia repair with pledgets and mesh. A two-tailed research hypothesis will be used to determine whether there are differences between the two arms
详细描述
This is a prospective, single-center, randomized, two-arm trial assessing the impact of Ovitex mesh on paraesophageal hernia recurrence. This study will occur at Cleveland Clinic Foundation in Cleveland, OH. A total of 164 patients will be enrolled in this study. The anticipated accrual rate is approximately 7 per month for a total accrual period of approximately 24 months.
Patients may be enrolled into the study provided all inclusion and no exclusion criteria are met as specified in Section 4. Subjects will be evaluated through hospital discharge and return for follow-up visits at 1 month (10 days-45 days) and annually through 2 years postoperatively. Total estimated duration for the trial is 4 years for the primary outcome with an additional 3 years for longer term follow up resulting in a total of 7 years.
Several approaches to limiting bias are included in this trial.
- Intraoperative bias- limited by randomization just prior to crural closure
- Blinded outcome assessors/study team including 3 surgeons reviewing recurrence imaging
- Single blind - patients blinded to intervention Devices included in this study include Ovitex mesh and pledgets which are both used to reinforce the repair at the crura. Ovitex mesh is FDA approved for this indication.
Study Endpoints Primary Endpoint The primary endpoint of this study is the binary 2-year rate of radiographic recurrence of the paraesophageal hernia, defined gastroesophageal junction at least 2 cm above the hiatus on upper GI studies, CT, or MRI. Anatomical recurrence assessed via imaging is the gold standard of diagnosing recurrence, and thus is the most appropriate primary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
Patients will be blinded to the intervention. Additionally, there will be blinded outcome assessors/study team including 3 surgeons reviewing recurrence imaging
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
- •18 years of age or older
- •Willing and able to provide informed consent
- •Willing and able to participate in long-term follow up including study visits and surveys
- •Type II, III, or IV hiatal hernia > 5 cm, confirmed via upper GI studies, CT, or MRI 5 cm or greater hernia confirmed intraoperatively
排除标准
- •Pregnancy
- •Allergy to any components of mesh
- •Patients undergoing PEHR with a concurrent bariatric procedure or other procedure to reduce stomach volume (sleeve gastrectomy, roux-en-y gastric bypass, duodenal switch, single-anastomosis gastric bypass, and partial or total gastrectomy)
- •Patients who have undergone previous hiatal hernia repair
结局指标
主要结局
Radiographic recurrence rate
时间窗: 2 years after surgery
The primary endpoint of this study is the binary 2-year rate of radiographic recurrence of the paraesophageal hernia, defined gastroesophageal junction at least 2 cm above the hiatus on upper gastrointestinal studies, CT, or MRI.
次要结局
- Reoperations(Throughout study up to 2 years after surgery)
- Patient quality of life as measured by the validated EQ5D survey(Preop, 30-day, 1-year, and 2-year timepoints after surgery)
- Patient satisfaction as measured by patient reported assessment(Preop, 30-day, 1-year, and 2-year timepoints after surgery)
- Comprehensive Complications Index (CCI)(Throughout study up to 2 years after surgery)
- Immediate recurrence(Within 45 days from surgery)
- Clavien-Dindo Complications(Throughout study up to 2 years after surgery)
- Patient quality of life as measured by the validated decision regret scale survey(1-year, and 2-year timepoints after surgery)
- Patient quality of life as measured by presence of patient reported dysphagia symptoms(Preop, 30-day, 1-year, and 2-year timepoints after surgery)
- Patient quality of life as measured by the validated EQ-VAS survey(Preop, 30-day, 1-year, and 2-year timepoints after surgery)
- Patient quality of life as measured by the GERD-HRQL scale(Preop, 30-day, 1-year, and 2-year timepoints after surgery)
- Intraoperative complications(At time of surgery)
- Foregut complications requiring reintervention(Throughout study up to 2 years after surgery)
研究者
David Krpata
Professor of Surgery, CCF Lerner College of Medicine
The Cleveland Clinic