robotic surgical platform
Procedurerobot-assisted laparoscopic inguinal hernia repair (rTAR)
NCT Number: NCT06599515
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
AZ Sint-Vincentius, Deinze, Belgium
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
robot-assisted laparoscopic inguinal hernia repair (rTAR)
Time frame: Minutes, up to 4 hours
Comparison of operative times for rTAPP
Time frame: until 30 days after the surgical procedure
Evaluation of short term complications
Time frame: until 30 days after the surgical procedure
Evaluation of quality of life 1 month after surgery, using the EuraHS Quality of Life questionnaire, a lower score means a better quality of life
Contact information is provided by the study sponsor or research team.
Ella Hermie, MSc
CONTACT
Filip Muysoms, MD, PhD
CONTACT
Algemeen Ziekenhuis Maria Middelares
Other
A Multicenter Comparative Prospective Observational Cohort Study About Robot-assisted Laparoscopic Inguinal Hernia Repair Using Two Different Robotic Systems
Acronym: SUSHI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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