SetUp Study for HugoTM RAS Inguinal Hernia Repair

NCT06599515 | Recruiting

• 1 other identifier: SUSHI
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Inguinal Hernia

Keywords

robot-assisted laparoscopic inguinal hernia repair

Outcome Measures

Primary Outcomes (1)

• Operative times

  Comparison of operative times for rTAPP

  Minutes, up to 4 hours

Secondary Outcomes (2)

• Short-term complications

  until 30 days after the surgical procedure

• Quality of Life (QoL) one month after surgery

  until 30 days after the surgical procedure

Study Arms (2)

HugoTM Ras (Medtronic) robotic system

ACTIVE COMPARATOR

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

daVinci Xi (Intuitive Surgical) robotic system

ACTIVE COMPARATOR

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

Interventions

robotic surgical platform PROCEDURE

robot-assisted laparoscopic inguinal hernia repair (rTAR)

HugoTM Ras (Medtronic) robotic system; daVinci Xi (Intuitive Surgical) robotic system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Algemeen Ziekenhuis Maria Middelares: lead

Study Sites (2)

AZ Sint-Vincentius

Deinze, Belgium

RECRUITING

AZ Maria Middelares

Ghent, 9000, Belgium

NOT YET RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Filip Muysoms, MD, PhD

CONTACT

+32 9 246 74 00; Filip.Muysoms@mijnziekenhuis.be

Ella Hermie, MSc

CONTACT

+32 9 246 17 03; ella.hermie@mijnziekenhuis.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: daVinci Xi (Intuitive Surgical) robotic system
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: HugoTM Ras (Medtronic) robotic system

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2023
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)