SetUp Study for HugoTM RAS Inguinal Hernia Repair
ConditionInguinal Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlgemeen Ziekenhuis Maria Middelares
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Recurrent hernias after previous preperitoneal mesh placement.
Inguinal hernias after abdominal prostatectomy.
Pregnancy.
Emergency surgery.
Trial design
Design model
Parallel
Treatments tested in this trial
robotic surgical platform
Procedure/Surgeryrobot-assisted laparoscopic inguinal hernia repair (rTAR)
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: HugoTM Ras (Medtronic) robotic systemActive comparator 1 intervention
Group B: daVinci Xi (Intuitive Surgical) robotic systemActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Operative times
Comparison of operative times for rTAPP
Time frame
Minutes, up to 4 hoursSecondary outcomes
1
Short-term complications
Evaluation of short term complications
Time frame
until 30 days after the surgical procedure2
Quality of Life (QoL) one month after surgery
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
Time frame
until 30 days after the surgical procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov