A Randomized Pilot Trial of Platelet Rich Plasma Use in Hiatal Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Hernia recurrence on postoperative upper endoscopy or video esophagram
研究概览
简要总结
Rationale: Gastroesophageal reflux disease (GERD) is a common disease caused by a dysfunctional lower esophageal sphincter and an abnormal esophageal hiatus or hiatal hernia. Approximately 30% of large hiatal hernias will recur after surgery, in part due to weak connective tissue at the hiatus. Platelet rich plasma (PRP) is a promising autologous therapy that may address this shortcoming by substantially enhancing wound healing of the hiatus after repair.
Intervention: PRP will be applied to mesh used in hiatal hernia repair.
Objectives: The objective of this study is to determine the efficacy of PRP in hiatal hernia compared to traditional hernia repair without PRP.
Study population: 150 patients 18 years and older with large (>5cm) paraesophageal hernias.
Study methodology and study arms: a 1:1 allocation ration will be used to randomly assign 75 patients to the experimental arm (PRP with mesh) and 75 patients to the control arm (mesh only).
Study outcomes: The primary outcome will be 1-year postoperative hernia recurrence based on video esophagram and/or upper endoscopy. The secondary outcome will be GERD-Health Related Quality of Life (GERD-HRQL) scores and dysphagia scores at 6 and 12 months.
Follow-up: Patients who undergo fundoplication and hiatal hernia repair with mesh are seen in clinic for follow-up at two weeks, six weeks, six months, one year, and annually thereafter. Video esophagram or upper endoscopy will be performed at 1 year after surgery to assess the primary outcome. The investigators secondary outcome of reduction in GERD-HRQL score will be determined by a difference in the GERD-HRQL score from the preoperative score to the postoperative scores taken at 6 months and 1 year. The investigators secondary outcome of dysphagia will be determined by EAT-10 scores taken at 6 months and 1 year.
Statistics/Analysis: Descriptive statistics will be used. Intention to treat and per protocol analyses will be performed. Frequentist and Bayesian statistical analyses will be used to determine statistically and clinically important outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The research personnel will be aware of whether the patient is in the treatment or control arm. The patient will be blinded from this knowledge.
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
- •Documented hiatal hernia > 5cm on preoperative video esophagram or upper endoscopy
排除标准
- •Non-English speaking patients
- •Prior antireflux surgery
- •Platelet count less than 100,000
- •History of platelet dysfunction
- •Antiplatelet therapy up to ten days prior to surgery
- •Corticosteroids use up to one month before surgery
- •Active malignancy or treatment for cancer within the last year
- •Pregnancy or active breastfeeding
- •Active smoking
研究组 & 干预措施
PRP
Patients in this treatment arm will have PRP injected into the crura of the diaphragm and coating the mesh placed during the hiatal hernia repair.
干预措施: Hiatal Hernia Repair with Platelet Rich Plasma (Procedure)
No PRP
Patients in this arm will undergo an identical surgical procedure, however will not have the addition of PRP injected into the cura of the diaphragm or onto the mesh placed during the hiatal hernia repair.
干预措施: Hiatal Hernia Repair without Platelet Rich Plasma (Procedure)
结局指标
主要结局
Hernia recurrence on postoperative upper endoscopy or video esophagram
时间窗: one year
A hernia of 2 cm or greater on postoperative endoscopy or video esophagram will indicate a recurrence of hiatal hernia
次要结局
- Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) survey score(6 and 12 months)
- Proton Pump Inhibitor Use(6 and 12 months)
研究者
John Lipham
Professor
University of Southern California