ASPIRE: A proSpective Evaluation of PaIn After Non-complex ventRal hErnia Repair
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Change in pain score assessed by the NRS from baseline to 14 days
研究概览
简要总结
The study aims to evaluate outcomes relating to pain and QOL after robotic-assisted or laparoscopic non-complex ventral hernia repair.
详细描述
This is a prospective, observational, study across robotic-assisted and laparoscopic primary (non-recurrent) umbilical and incisional hernia repair. The study aims to evaluate pain and QOL outcomes through 30 days. During the post-operative period through 30 days, pain medication intake, subject reported pain and quality of life 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
- Cohort
- 时间视角
- Prospective
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
- 否
入选标准
- •Subject is between 18 and 80 years of age.
- •Subject is a candidate for an elective primary (non-recurrent) ventral hernia repair.
- •Ventral hernia repair that will require mesh placement
排除标准
- •Subject is contraindicated for general anesthesia or surgery.
- •Subject with a ventral hernia that will require retromuscular mesh placement or employ a technique, including (but not limited to) external oblique release, Rives- Stoppa, eTEP Rives-Stoppa, transversus abdominis release, other component separation techniques (i.e. anterior component separation) or eTEP transversus abdominis release.
- •Subject has a recurrent hernia.
- •Subject who will have an emergent hernia repair.
- •Subject with a history of chronic pain and/or taking daily pain medications for >6 weeks.
- •Subject with a history of substance abuse (excluding marijuana) and/or current (within 30 days) narcotic use.
- •Current marijuana use that the subject is unwilling to discontinue within the 14 days prior to surgery.
- •Subject with a history of MRSA infection.
- •Subject with HbA1c level > 8.5%.
- •Use of Exparel during the surgical procedure.
- •Subject who will undergo a concomitant hernia repair or any other concomitant procedure.
- •Current nicotine use (including vaping) within the past 30 days.
- •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 study requirements or ability to provide informed consent.
- •Subject belonging to other vulnerable population, e.g, prisoner or ward of the state.
- •Subject is currently participating in another interventional or investigational research study.
结局指标
主要结局
Change in pain score assessed by the NRS from baseline to 14 days
时间窗: 14 days
Change in patient reported pain scores assessed by the Numeric Rating Scale (NRS) from 1-10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Change in narcotic usage from 1 day post-procedure to 14 days post-procedure
时间窗: 14 days
Narcotic usage after the ventral hernia repair as determined through use of a patient reported pain medication log.
Change in pain score assessed by the PROMIS 3a from baseline to 14 days
时间窗: 14 days
Change in patient reported pain scores assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey, with a scale from 1-5; 1 meaning no pain and 5 meaning severe pain.
次要结局
- Need for refill prescription pain medication usage from 1 day post-procedure to 30 days post-procedure(30 days)
- Length of hospital stay (LOS)(Procedure start time to discharge from the hospital (check out time), up to an approximate of one week)
- Change in Quality of Life assessment: EuraHS-QOL from baseline to 30 days(30 days)
- Change in narcotic usage from 1 day post-procedure to 30 days post-procedure(30 days)
- Change in OTC pain medication usage from 1 day post-procedure to 30 days post-procedure(30 days)
- Incidence of postoperative adverse events related to the ventral hernia repair through 30 days post-procedure(30 days)
- Change in Quality of Life assessment: EQ-5D-3L (EQ) from baseline to 14 days(14 days)
- Incidence of intraoperative adverse events related to the ventral hernia repair(Intraoperative)