SetUp Study for HugoTM RAS Inguinal Hernia Repair (SUSHI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: robotic surgical platform

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ella Hermie, MSc; Phone Number: +32 9 246 17 03; Email: ella.hermie@mijnziekenhuis.be
• Study Contact Backup: Name: Filip Muysoms, MD, PhD; Phone Number: +32 9 246 74 00; Email: filip.muysoms@mijnziekenhuis.be

Study Locations

• Belgium
  • Deinze, Belgium
    • Recruiting
    • AZ Sint-Vincentius
    • Contact: Filip Muysoms, MD, PhD; Phone Number: +32 9 387 70 24; Email: filip.muysoms@mijnziekenhuis.be
    • Contact: Filip Muysoms, MD, PhD
  • Ghent, Belgium, 9000
    • Not yet recruiting
    • AZ Maria Middelares
    • Contact: Filip Muysoms, MD, PhD; Phone Number: +32 9 246 74 00; Email: filip.muysoms@mijnziekenhuis.be
    • Contact: Filip Muysoms, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HugoTM Ras (Medtronic) robotic system; The patient is positioned supine position and a tilt of Trendelenburg of 12 degrees is given. A Verres needle insufflation at Palmers' point at the left subcostal margin will be done to achieve a pneumoperitoneum of 12 mmHg. Subsequently, a trocar of 12 mm is placed at the upper margin of the umbilicus using an optical trocar. Two further trocars of 8 mm are placed left and right side at 7 to 8 cm distance from the umbilical trocar and 2 cm caudal from the umbilical trocar. The setup of the arms, tilt and angles are done using the setup guide. The operation is performed using a scope with a 0°-degree angle. As instruments we have a fenestrated bipolar forceps in the left hand and a monopolar curved scissors in the right hand. Mesh used will be DextileTM Anatomical Mesh X-Large of 16x12 cm. There is a left sided and a right sided version and in bilateral hernias the meshes will overlap on the midline. The peritoneum is closed using a barbed suture (V-Loc 3/0) of 15 cm in length.	Procedure: robotic surgical platform; robot-assisted laparoscopic inguinal hernia repair (rTAR)
Active Comparator: daVinci Xi (Intuitive Surgical) robotic system; An 8-mm trocar will be placed at the supraumbilical position after creation of pneumoperitoneum using a Verress needle with an intra-abdominal pressure of 12 mmHg. Two additional trocars (8 mm) are placed bilaterally in the flank at the level of the umbilicus under direct vision. The distance between the lateral trocars and the umbilical trocar will be 7 cm at minimum. The Progrip™ Laparoscopic Self-Fixating Mesh of 12×16 cm (anatomic version, Medtronic, Minneapolis, MN, US) will be used. The suture will be a slowly absorbable barbed suture 15 cm in length (V-Loc™ 90, Medtronic, Minneapolis, MN, US). The trocars are docked to the robotic arms, with the endoscope at the umbilicus. Inguinal hernia repair will be performed according to the standard surgical principle.	Procedure: robotic surgical platform; robot-assisted laparoscopic inguinal hernia repair (rTAR)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term complications	Evaluation of short term complications	until 30 days after the surgical procedure
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	until 30 days after the surgical procedure

Collaborators and Investigators

• Sponsor: Algemeen Ziekenhuis Maria Middelares

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: robot-assisted laparoscopic inguinal hernia repair
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: SUSHI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No