Clinical trial NCT06599515: SetUp Study for HugoTM RAS Inguinal Hernia Repair
Official title: A Multicenter Comparative Prospective Observational Cohort Study About Robot-assisted Laparoscopic Inguinal Hernia Repair Using Two Different Robotic Systems
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inguinal Hernia
Keywords: robot-assisted laparoscopic inguinal hernia repair
Lead sponsor: Algemeen Ziekenhuis Maria Middelares
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HugoTM Ras (Medtronic) robotic system
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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:

* Recurrent hernias after previous preperitoneal mesh placement.
* Inguinal hernias after abdominal prostatectomy.
* Pregnancy.
* Emergency surgery.
* Age below 18 years.
* Absence of informed consent.

Primary outcomes:
measure: Operative times
timeFrame: Minutes, up to 4 hours
Secondary outcomes:
measure: Short-term complications
timeFrame: until 30 days after the surgical procedure
measure: Quality of Life (QoL) one month after surgery
timeFrame: until 30 days after the surgical procedure
Other outcomes:
Locations:
city: Deinze
country: Belgium
facility: AZ Sint-Vincentius
city: Ghent
country: Belgium
facility: AZ Maria Middelares
Study officials:
References: