A Monocenter Comparative Prospective Observational Cohort Study About Robot-assisted Laparoscopic Inguinal Hernia Repair Using Two Different Robotic Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Operative times
研究概览
简要总结
The goal of this observational cohort study is to evaluate the evolution of the operative time in performing robotic-assisted laparoscopic inguinal hernia repair (rTAPP) during the learning curve of the first 50 patients using the HugoTM Ras (Medtronic) robotic system using the setup guide.
This will be compared to the operative time for rTAPP in 50 patients performed by the same surgeon in another hospital. This data was collected in an earlier similar study with the start of the experience using the daVinci Xi (Intuitive Surgical) robotic system.
详细描述
As a result of human cadaveric sessions to evaluate the approach of inguinal hernia repair using the Hugo RAS robotic system a setup guide was produced. Preclinic tests on dummies, cadaveric models and porcine models were performed. During a first session using dummies, the existing set-up guide proposed by US surgeons was tested and validated.
To evaluate the evolution of the operative time in performing robotic assisted laparoscopic inguinal hernia repair (rTAPP) during the learning curve of the first 50 patients using the HugoTM Ras (Medtronic) robotic system using the setup guide at the Sint Vincentius Hospital in Deinze. This will be compared to a previously performed and similar study with the start of the experience with the daVinci Xi (Intuitive Surgical) robotic system in AZ Maria Middelares in 2016.
Patient data and outcome data will be collected. A follow-up of 1 month postoperative is foreseen for the evaluation of short-term complications and quality of life 1 month after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
盲法说明
daVinci Xi (Intuitive Surgical) robotic system
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients planned for a minimal invasive (robotic assisted laparoscopic) inguinal hernia repair during the study period will be invited to take part in the study. Both unilateral and bilateral hernias will be included.
排除标准
- •Recurrent hernias after previous preperitoneal mesh placement.
- •Inguinal hernias after abdominal prostatectomy.
- •Pregnancy.
- •Emergency surgery.
- •Age below 18 years.
- •Absence of informed consent.
研究组 & 干预措施
HugoTM Ras (Medtronic) robotic system
The patient is positioned supine position and a tilt of Trendelenburg of 12 degrees is given. A Verres needle insufflation at Palmers' point at the left subcostal margin will be done to achieve a pneumoperitoneum of 12 mmHg. Subsequently, a trocar of 12 mm is placed at the upper margin of the umbilicus using an optical trocar. Two further trocars of 8 mm are placed left and right side at 7 to 8 cm distance from the umbilical trocar and 2 cm caudal from the umbilical trocar. The setup of the arms, tilt and angles are done using the setup guide. The operation is performed using a scope with a 0°-degree angle. As instruments we have a fenestrated bipolar forceps in the left hand and a monopolar curved scissors in the right hand. Mesh used will be DextileTM Anatomical Mesh X-Large of 16x12 cm. There is a left sided and a right sided version and in bilateral hernias the meshes will overlap on the midline. The peritoneum is closed using a barbed suture (V-Loc 3/0) of 15 cm in length.
干预措施: robotic surgical platform (Procedure)
结局指标
主要结局
Operative times
时间窗: Minutes, up to 4 hours
Comparison of operative times for rTAPP
次要结局
- Short-term complications(until 30 days after the surgical procedure)
- Quality of Life (QoL) one month after surgery(until 30 days after the surgical procedure)
研究者
Filip Muysoms
Principal Investigator
Algemeen Ziekenhuis Maria Middelares