Mesh and Fixation Combinations in Laparoendoscopic Groin Hernia Repair: Association With Chronic Postoperative Pain. A Swedish Hernia Registry Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15,360
- 主要终点
- Relative risk for postoperative pain at 1 year
研究概览
简要总结
The study attempts to quantify the relative risks for chronic postoperative inguinal pain (CPIP) depending on different combinations of mesh and mesh fixation. For this purpose the investigators will analyze data from the Swedish Hernia Registry (SHR).
详细描述
This is an open cohort study design where the investigators will analyze existing data that have been prospectively collected in the Swedish Hernia Registry (SHR), which covers > 95% of all groin hernia repairs in Sweden. The very large cohort of approximately 25,000 primary TEP (totally extraperitoneal) and TAPP (transabdominal preperitoneal) repairs enable assessment of the relative risks for CPIP depending on different combinations of mesh and mesh fixation. Each participant was entered at the date of surgery when demographic and intraoperative data were registered. The possible presence of CPIP after 1 year postoperative was evaluated with a PROM questionnaire.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All laparoendoscopic repairs for groin hernia that have been registered in the SHR from September 1, 2012, until December 31, 2018.
排除标准
- •Open repairs.
- •Hernioplasties that were converted from laparoscopic to open surgery.
- •Bilateral repairs.
- •Surgery merely for hernia (eg obturator) other than lateral, medial or femoral.
- •Age < 15 years.
- •Patients not having a 10-digit state-assigned Patient Identification Number.
结局指标
主要结局
Relative risk for postoperative pain at 1 year
时间窗: 1 year
Chronic postoperative inguinal pain, measured by the Short Form Inguinal Pain Questionnaire (sf-IPQ)
次要结局
- Reoperation(1-8 years)
研究者
Bengt Novik
MD, PhD, SSOD
Karolinska Institutet