PREPARE: A PRospective Evaluation of Pain After Inguinal Hernia REpair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Change in Pain Scores from Baseline to 14 Days
研究概览
简要总结
This study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted inguinal hernia repair.
详细描述
This is a prospective, multi-center, observational pilot study comparing outcomes of pain and quality of life after inguinal hernia repair between open, laparoscopic, and robotic-assisted surgical approaches. The study will focus on short-term outcomes through 3 months post-operation. During the post-operative period through 3 months, pain medication intake, pill count, subject-reported pain (on post-operative days 1-3 and 14 days post-surgery), and quality of life (at 14 days, 30 days, and 3 months post-surgery), incidence of intra- and post-operative complications, and time to return to normal activity 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 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 inguinal hernia repair.
排除标准
- •Subject receiving a bilateral open repair.
- •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 and/or current (within 30 days) narcotic use.
- •Subject with a history of methicillin-resistant Staphylococcus aureus (MRSA) infection.
- •Diabetic subjects requiring insulin.
- •Subject with recurrent hernias.
- •Subject who will require the use of Exparel during the surgical procedure.
- •Subject who will undergo a concomitant hernia repair or any other concomitant procedure.
- •Current marijuana use that the subject is unwilling to discontinue within the 14 days prior to surgery.
- •Subject is contraindicated for surgery.
- •Subject has a known bleeding or clotting disorder.
- •Pregnant or suspect 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 unable to comply with the follow-up visit schedule.
- •Subject is currently participating in another research study.
结局指标
主要结局
Change in Pain Scores from Baseline to 14 Days
时间窗: 14 days post-surgery
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Change in Pain Scores from Baseline to 1 Day
时间窗: 1 day post-surgery
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Change in Pain Scores from Baseline to 2 Days
时间窗: 2 days post-surgery
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Change in Pain Scores from Baseline to 3 Days
时间窗: 3 days post-surgery
Change in patient-reported pain scores assessed by the Brief Pain Inventory Tool (BPI), with scores on individual questions ranging from 0% (no relief) to 100% (complete relief) or 0 (no pain/does not interfere) to 10 (pain as bad as you can imagine/completely interferes).
Change in Narcotic Usage from 1 Day Post-Surgery to 3 Months Post-Surgery
时间窗: 3 months post-surgery
Narcotic usage after the inguinal hernia repair procedure as determined by pill counts at study follow-up visits
Change in Narcotic Usage from 1 Day Post-Surgery to 30 Days Post-Surgery
时间窗: 30 days post-surgery
Narcotic usage after the inguinal hernia repair procedure as determined by pill counts at study follow-up visits
Change in Narcotic Usage from 1 Day Post-Surgery to 14 Days Post-Surgery
时间窗: 14 days post-surgery
Narcotic usage after the inguinal hernia repair procedure as determined by pill counts at study follow-up visits
Change in Narcotic Usage from 1 Day Post-Surgery to 7 Days Post-Surgery
时间窗: 7 days post-surgery
Narcotic usage after the inguinal hernia repair procedure as determined by patient Pain Diary completed at home
次要结局
- Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 7 Days Post-Surgery(7 days post-surgery)
- Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 3 Months Post-Surgery(3 months post-surgery)
- Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 30 Days Post-Surgery(30 Days post-surgery)
- Change in Over the Counter Pain Medication Usage from 1 Day Post-Surgery to 14 Days Post-Surgery(14 Days post-surgery)
- Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 3 Months Post-Surgery(3 months post-surgery)
- Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 30 Days Post-Surgery(30 Days post-surgery)
- Change in Quality of Life Assessment: EQ-5D-5L (EQ) from Baseline to 14 Days Post-Surgery(14 Days post-surgery)
- Operative Time(Intra-operative)
- Length of Hospital Stay (LOS)(Admission to the hospital to discharge from the hospital (check out time), up to an approximate of one week)
- Conversion to Open(Intra-operative)
- Number of Complications(Intra-operative through the 3 month follow-up period)