Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599515
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
SetUp Study for HugoTM RAS Inguinal Hernia Repair
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Comparative Prospective Observational Cohort Study About Robot-assisted Laparoscopic Inguinal Hernia Repair Using Two Different Robotic Systems
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUSHI
Brief Summary:
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
Researchers will compare to the operative time for rTAPP of 50 patients by the same surgeon in another hospital using the daVinci Xi Intuitive Surgical robotic system
Researchers will compare to the operative time for rTAPP of 50 patients by the same surgeon in another hospital using the daVinci Xi Intuitive Surgical robotic system
Detailed Description:
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 the operative time for rTAPP of 50 patients by the same surgeon in General hospital Maria Middelares using the daVinci Xi Intuitive Surgical robotic system
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
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 the operative time for rTAPP of 50 patients by the same surgeon in General hospital Maria Middelares using the daVinci Xi Intuitive Surgical robotic system
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None