Minimal ACCess Hernia InguinAlis Treatment of Hernia (MACCHIATOH Study): Prospective Cohort Study of Single-port Robotic Suprapubic Inguinal Hernia Repair (SPIN Procedure)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Operative time
研究概览
简要总结
Evaluation of the perioperative and patient reported outcomes of a new surgical technique: single-port robotic suprapubic inguinal hernia repair (SPIN procedure).
详细描述
The MACCHIATOH study (Minimal ACCess Hernia InguinAlis Treatment of Hernia) is a prospective, single-centre, single-arm IDEAL Stage 2b cohort study conducted at AZ Maria Middelares (Ghent, Belgium). The study evaluates a novel single-port robotic suprapubic inguinal hernia repair technique (SPIN procedure) in a consecutive series of 30 patients undergoing primary inguinal hernia repair.
The SPIN procedure was developed to overcome some limitations of previously described single-port robotic approaches by using a suprapubic access route, which may provide improved access to the myopectineal orifice and potentially reduce the risk of access-site incisional hernias.
The study hypothesizes that the SPIN procedure is a safe and efficient technique without increased complication risk and may result in less postoperative pain, improved cosmetic outcomes, and equal or better patient satisfaction compared with current minimally invasive approaches. Patients will be followed for 12 months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 with a primary inguinal hernia, either unilateral or bilateral
排除标准
- •Recurrent inguinal hernia after preperitoneal repair
- •Irreducible scrotal hernia
- •Post-prostatectomy
- •Laparotomy in the lower abdomen
- •Pregnancy
- •Contra-indication for general anaesthesia
研究组 & 干预措施
single-port robotic suprapubic inguinal hernia repair
干预措施: single-port robotic suprapubic inguinal hernia repair (Procedure)
结局指标
主要结局
Operative time
时间窗: During surgery
Total operative time from skin incision to skin closure
Technical errors with the robotic system
时间窗: During surgery
Number and type of technical errors or device-related issues encountered during the procedure.
Complication Rate
时间窗: From surgery until 1 month postoperatively
Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification
次要结局
- Body Image Questionnaire Score(Preoperatively, 1 month , and 1 year postoperatively)
- hernia recurrence(1 year postoperatively)
- EuraHS Quality of Life score(Preoperatively, 1 month and 1 year postoperatively)
研究者
Filip Muysoms
Head of Surgery Department
Algemeen Ziekenhuis Maria Middelares