SetUp Study for HugoTM RAS Inguinal Hernia Repair

Last updated: September 13, 2024
Sponsor: Algemeen Ziekenhuis Maria Middelares
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Treatment

robotic surgical platform

Clinical Study ID

NCT06599515
SUSHI
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: robotic surgical platform
Phase:
Study Start date:
September 15, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • AZ Sint-Vincentius

    Deinze,
    Belgium

    Active - Recruiting

  • AZ Maria Middelares

    Ghent, 9000
    Belgium

    Site Not Available

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