RECOVER: a PRospECtive EvaluatiOn of Pain After Retromuscular VEntRal Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 4
- 主要终点
- Non-opioid prescription pain medication usage
研究概览
简要总结
The study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted retromuscular ventral hernia repair.
详细描述
This is a prospective, multicenter, observational study assessing outcomes relating to pain and quality of life for subjects undergoing open, laparoscopic, or robotic-assisted retromuscular ventral hernia repair. The study will focus on short-term post-operative outcomes through 3 months. The study will also collect recurrence data through 1 year. During the post-operative period through 3 months, pain medication intake, subject reported pain (on post-operative day 7, 14, 21, 28, and 3 months) and quality of life (on day 28, 3 months, and 1 year) and incidence of intra-operative and post-operative adverse events related to the ventral hernia repair will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is between 18 and 89 years of age
- •Subject is a candidate for an elective retromuscular ventral hernia repair under general anesthesia
- •Subject has access to complete study assessments electronically and agrees to comply with all follow-up requirements
- •Ventral hernia is >= 4cm
排除标准
- •Subject who will have an emergent hernia repair
- •Subject has a parastomal hernia (i.e. hernia related to ostomy formation)
- •Subject with a history of chronic pain and/or taking daily pain medication for >6 weeks
- •Subject wtih a history of substance abuse (excluding marijuana) and/or current (within 30 days) narcotic use
- •Subject with a history of MRSA infection
- •Subject with HbA1c level > 8.5%
- •Subject undergoing a minimally invasive (MIS) repair who will require the use of Exparel during the surgical procedure
- •Subject who will undergo a concomitant hernia repair or any other concomitant procedure
- •Subject has cirrhosis
- •Current nicotine use (including vaping) within the past 30 days
- •Subject is contraindicated for general anesthesia or surgery
- •Subject has a known bleeding or clotting disorder
- •Pregnant or suspected pregnancy
- •Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with the study requirements or ability to provide informed consent
- •Subject belonging to other vulnerable population, e.g., prisoner or ward of state
- •Subject is currently participating in another interventional research study
结局指标
主要结局
Non-opioid prescription pain medication usage
时间窗: 4 weeks
Non-opioid prescription pain medication usage related to the retromuscular ventral hernia repair
Pain scores
时间窗: 7 days
Subject reported pain scores assessed by the Subject-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey.
Narcotic usage
时间窗: 4 weeks
Narcotic usage (in hospital and out of hospital) taken for the purpose of managing abdominal pain after the ventral hernia repair.
次要结局
- Narcotic usage(3 months)
- Non-opioid prescription pain medication usage(3 months)
- Over the counter pain medication usage(4 weeks)
- Hospital length of stay(Start of procedure to discharge from the hospital (check out time), up to an approximate of one week)
- Need for refill prescription pain medication(4 weeks)
- PROMIS 3a pain scores(4 weeks)
- Incidence of postoperative adverse events related to the retromuscular ventral hernia repair(3 months)
- Incidence of intraoperative adverse events related to the retromuscular ventral hernia repair(intraoperatve)
- EQ-5D-3L QOL scores(4 weeks)
- Hernia recurrence(1 year)