Combined APProach of Umbilical ConComitant With Inguinal Hernia
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
- 1
- 主要终点
- Technical errors with the robotic system
研究概览
简要总结
Evaluation of the perioperative and patient reported outcomes of a new surgical technique: robotic inguinal hernia repair using the Da Vinci SP system.
详细描述
The CAPPUCCINOH study (Combined APProach of Umbilical ConComitant with Inguinal Hernia Repair) is a prospective single-centre, single-arm cohort study conducted at AZ Maria Middelares, Ghent, Belgium. The study evaluates a novel surgical technique combining robotic-assisted inguinal hernia repair with concomitant umbilical hernia repair using the da Vinci Single Port (SP) system.
Building on the feasibility demonstrated in the ESPRITH study, the umbilical hernia defect is used as the single access site for the robotic procedure. Following inguinal hernia repair, the umbilical defect is repaired either by primary closure or with preperitoneal mesh reinforcement according to current guidelines and defect size.
The primary objective is to assess the safety and feasibility of this approach by evaluating operative time, technical errors, successful mesh placement, and perioperative complications. Secondary objectives include assessment of patient-reported outcomes, quality of life, body image, and hernia recurrence at one year postoperatively.
Patients will be followed for one year after surgery, with evaluations performed during hospitalization and at one month and one year postoperatively. The study aims to generate clinical evidence on the safety, effectiveness, and patient experience of robotic single-port repair for concomitant inguinal and umbilical hernias.
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, in association with a primary umbilical hernia of >1
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
Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair
干预措施: Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair (Procedure)
Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair
干预措施: da Vinci Single Port Surgical System (Device)
结局指标
主要结局
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.
Operative time
时间窗: During surgery
Total operative time from skin incision to skin closure
Complication Rate
时间窗: From surgery until 1 month postoperatively
Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification
Success rate
时间窗: From surgery until planned follow-up 1 month potoperatively
success rate of preperitoneal mesh placement
次要结局
- Body Image Questionnaire Score(Preoperatively, 1 month , and 1 year postoperatively)
- EuraHS Quality of Life score(Preoperatively, 1 month and 1 year postoperatively)
- Number of Participants With Hernia Recurrence(1 year postoperatively)
研究者
Filip Muysoms
Head of Surgery Department
Algemeen Ziekenhuis Maria Middelares
