Cost-Effectiveness of Retromuscular Ventral Hernia Repair: Open, Laparoscopic and Robotic Approaches
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Length of hospital stay
研究概览
简要总结
This prospective observational study aims to evaluate the clinical outcomes and cost-effectiveness of retromuscular midline ventral hernia repair using open, laparoscopic and robotic approaches. Patients undergoing elective repair are included and followed to assess postoperative complications, length of hospital stay, recurrence and quality of life. In addition, a cost-effectiveness analysis will be performed from the perspective of the Spanish National Health System. The study is currently ongoing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Adults ≥ 18 years
- •Patients scheduled for elective retromuscular repair of midline ventral hernia
- •Primary hernia or recurrent hernia without previous retromuscular repair
- •Hernia defect width between 5 and 12 cm (EHS W2-W3)
- •Ability to understand the study and provide informed consent
排除标准
- •Contraindication to general anesthesia
- •Contraindication to minimally invasive or open surgery
- •Body mass index (BMI) > 35 kg/m²
- •ASA physical status > IV
- •Previous retromuscular hernia repair
- •Lateral or parastomal hernias
- •Emergency surgery
- •Advanced disease with life expectancy < 2 years
- •Pregnancy or planned pregnancy during follow-up
- •Conditions significantly affecting wound healing or surgical risk (e.g., severe immunosuppression, active chemotherapy, connective tissue disorders)
研究组 & 干预措施
Open retromuscular repair
Patients undergoing open retromuscular midline ventral hernia repair acording to routine clinical practice
干预措施: Retromuscular ventral hernia repair (Procedure)
Open retromuscular repair
Patients undergoing open retromuscular midline ventral hernia repair acording to routine clinical practice
干预措施: Polypropylene mesh (Device)
Open retromuscular repair
Patients undergoing open retromuscular midline ventral hernia repair acording to routine clinical practice
干预措施: Standard perioperative care (Other)
Laparoscopic retromuscular repair
Patients undergoing laparoscopic retromuscular midline ventral hernia repair acording to routine clinical practice
干预措施: Retromuscular ventral hernia repair (Procedure)
Laparoscopic retromuscular repair
Patients undergoing laparoscopic retromuscular midline ventral hernia repair acording to routine clinical practice
干预措施: Polypropylene mesh (Device)
Laparoscopic retromuscular repair
Patients undergoing laparoscopic retromuscular midline ventral hernia repair acording to routine clinical practice
干预措施: Standard perioperative care (Other)
Robotic retromuscular repair
Patients undergoing robotic retromuscular midline ventral hernia repair acording to routine clinical practice
干预措施: Retromuscular ventral hernia repair (Procedure)
Robotic retromuscular repair
Patients undergoing robotic retromuscular midline ventral hernia repair acording to routine clinical practice
干预措施: Polypropylene mesh (Device)
Robotic retromuscular repair
Patients undergoing robotic retromuscular midline ventral hernia repair acording to routine clinical practice
干预措施: Standard perioperative care (Other)
结局指标
主要结局
Length of hospital stay
时间窗: From date of surgery until hospital discharge (typically within 30 days postoperative)
次要结局
- Cost-effectiveness (ICER)(Cost-effectiveness (ICER) at 12 months)
- Postoperative complications (Clavien-Dindo grade ≥ II)(Postoperative complications (Clavien-Dindo grade ≥ II) within 30 days)
- Hernia recurrence(12 months)
- Health-related quality of life (EQ-5D-5L)(Health-related quality of life (EQ-5D-5L) at 6 and 12 months)
- Postoperative pain (VAS)(Postoperative pain (VAS) at 24 hours postoperatively and at hospital discharge (within 30 days after surgery))
研究者
Fátima Hinojosa Ramírez
Principal Investigator (Consultant Surgeon in General and Digestive Surgery)
Hospitales Universitarios Virgen del Rocío