SetUp Study for HugoTM RAS Inguinal Hernia Repair

A Monocenter Comparative Prospective Observational Cohort Study About Robot-assisted Laparoscopic Inguinal Hernia Repair Using Two Different Robotic Systems

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06599515

Acronym

SUSHI

Enrollment

Registered

2024-09-19

Start date

2023-09-15

Completion date

2025-02-07

Last updated

2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

robot-assisted laparoscopic inguinal hernia repair

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. 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.

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 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.

Interventions

PROCEDURErobotic surgical platform

robot-assisted laparoscopic inguinal hernia repair (rTAR)

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Operative times	Minutes, up to 4 hours	Comparison of operative times for rTAPP

Secondary

Measure	Time frame	Description
Short-term complications	until 30 days after the surgical procedure	Evaluation of short term complications
Quality of Life (QoL) one month after surgery	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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026