Prospective Cohort Study on Surgical Methods and Outcomes in Emergency Groin and Ventral Hernia Repairs in Finland
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 主要终点
- Number of patients with hernia recurrence
研究概览
简要总结
Emergency hernia repairs are associated with significantly higher morbidity and mortality compared with elective hernia surgery. In Finland, approximately 500 emergency groin hernia repairs and 600 ventral hernia repairs are performed annually, but treatment practices vary widely, and high-quality evidence is lacking.
This prospective multicenter cohort study will evaluate outcomes of emergency groin and ventral hernia repairs in Finland. About 600 patients will be recruited over two years and followed for five years postoperatively. The study will collect standardized data on patient demographics, comorbidities, surgical technique, intraoperative findings, postoperative course, and long-term follow-up. Quality of life will be assessed with RAND-36, AAS, and PROMIS questionnaires.
The primary endpoint is hernia recurrence within two years after surgery. Secondary outcomes include 30- and 90-day complications, infection rates, readmissions, recovery time, and quality of life at 1, 2, and 5 years.
The results will provide robust evidence to guide clinical practice, optimize surgical techniques, and refine urgency classification and surgeon competence requirements for emergency hernia repair.
详细描述
- Introduction and Background
Hernia surgery is among the most common surgical procedures, the majority performed as elective operations. However, the proportion of emergency procedures is considerable, and these are associated with significantly higher morbidity and mortality compared with elective surgery.
In Finland, approximately 500 emergency groin hernia repairs and 600 ventral hernia repairs are performed annually. Current treatment practices for emergency hernia surgery vary substantially, and scientific evidence on management and outcomes is lacking. Existing guidelines are partly outdated and largely based on expert opinion.
The aim of this study is to provide new, scientifically robust evidence on the outcomes, complications, and postoperative quality of life following emergency hernia surgery. 2. Study Objectives
The primary objective is to assess the short- and long-term outcomes of different surgical techniques in emergency groin and ventral hernia repairs. Specifically, the study will evaluate:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Emergency repair of a groin or ventral hernia
排除标准
- •Pregnancy
- •Age under 18 years
- •Advanced malignancy
- •Inability to follow up (e.g., long travel distance or poor functional status)
- •Participation in another study
- •Lack of informed consent
结局指标
主要结局
Number of patients with hernia recurrence
时间窗: 2 years
Either clinical or radiological recurrent hernia * Risk of recurrence and quality of life at 1, 2, and 5 years * Impact of wound and mesh infections, as well as other postoperative factors, on recurrence * Effectiveness and safety of different surgical techniques
次要结局
- Incidence of Postoperative complications 30 after the surgery(30 days)
- Surgical site infection rate 30 days after surgery(30 days)
- Quality of life RAND-36(5 years)
- Quality of life Activities Assessment Scale(5 years)
- Quality of life PROMIS(5 years)
- Number of patients who died 30 days after the surgery(30 days)
- Incidence of hernia related re-operations during the 5 years' follow-up(5 years)