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NCT Number: NCT06599515

SetUp Study for HugoTM RAS Inguinal Hernia Repair

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.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Sint-Vincentius, Deinze, Belgium

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About this study

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.

Who can participate

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

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

Treatment and study plan

robotic surgical platform

Procedure

robot-assisted laparoscopic inguinal hernia repair (rTAR)

Primary outcomes

  1. Operative times

    Time frame: Minutes, up to 4 hours

    Comparison of operative times for rTAPP

Secondary outcomes

  1. Short-term complications

    Time frame: until 30 days after the surgical procedure

    Evaluation of short term complications

  2. Quality of Life (QoL) one month after surgery

    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

Sponsors and collaborators

Lead sponsor

Algemeen Ziekenhuis Maria Middelares

Other

Registry information

Official study title

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

Acronym: SUSHI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Aug 7, 2026

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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