SetUp Study for HugoTM RAS Inguinal Hernia Repair

Not Applicable

Recruiting

• Conditions: Inguinal Hernia

• Registration Number: NCT06599515
• Lead Sponsor: Algemeen Ziekenhuis Maria Middelares

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.

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 Timeline

• Study Start: 2023-09-15
• Status Verified: 2024-08
• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-09-13
• Last Update Submitted: 2024-09-13
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Operative times	Minutes, up to 4 hours	Comparison of operative times for rTAPP

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

AZ Sint-Vincentius; 🇧🇪 Deinze, Belgium

AZ Maria Middelares; 🇧🇪 Ghent, Belgium