Evaluation of SupraPubic Robotic Extraperitoneal Single-port Site Operation for Ventral 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
- Operative Time
研究概览
简要总结
Evaluation of the perioperative outcomes of robotic suprapubic ventral hernia repair with the Da Vinci Singe Port (SP) system
详细描述
Ventral hernia repair using mesh reinforcement is recommended for primary ventral hernias larger than 1 cm. Robotic-assisted techniques may facilitate extraperitoneal mesh placement and improve surgical precision. The da Vinci Single Port (SP) system enables robotic surgery through a single incision and may further reduce invasiveness while improving cosmetic outcomes.
The ESPRESSOH study is a single-centre, single-arm prospective cohort study evaluating a novel robotic suprapubic extraperitoneal single-port technique (SP2 eTEP) for ventral hernia repair, with or without concomitant diastasis repair. The study aims to assess perioperative outcomes, safety, technical feasibility, patient-reported quality of life and body image, and hernia recurrence following surgery performed with the da Vinci SP system. Participants will be followed for one year after surgery.
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 midline ventral (umbilical or epigastric) classified as M1-M4 according to EHS classification with or without concomitant diastasis of the rectus abdominis muscles
排除标准
- •Post-prostatectomy
- •Post-preperitoneal mesh operation for inguinal hernia
- •Laparotomy in the lower abdomen
- •Caesarean section
- •Pregnancy
- •Contra-indication for general anaesthesia
研究组 & 干预措施
Robotic Suprapubic Ventral Hernia Repair (SP2 eTEP)
干预措施: SP2 eTEP (Procedure)
Robotic Suprapubic Ventral Hernia Repair (SP2 eTEP)
干预措施: da Vinci Single Port Surgical System (Device)
结局指标
主要结局
Operative Time
时间窗: During surgery
Duration of the robotic suprapubic ventral hernia repair procedure.
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 postoperatively, and 1 year postoperatively)
- Hernia Recurrence Rate(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