Inguinal HerniaSUSHINCT06599515
SetUp Study for HugoTM RAS Inguinal Hernia Repair
An observational study of Inguinal Hernia, run by Algemeen Ziekenhuis Maria Middelares at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- robotic surgical platform
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 2 sitesBelgium
- Study dates
- 15 Sep 2023to 7 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
None listed.
Who cannot join
- Recurrent hernias after previous preperitoneal mesh placement.
- Inguinal hernias after abdominal prostatectomy.
- Pregnancy.
- Emergency surgery.
- Age below 18 years.
- Absence of informed consent.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Monocenter 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.
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.
Read the 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 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.
- Conditions
- Inguinal Hernia
- Being tested
- robotic surgical platform
- Keywords
- robot-assisted laparoscopic inguinal hernia repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic surgical platformProcedure or surgery
robot-assisted laparoscopic inguinal hernia repair (rTAR)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: robotic surgical platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative times
Comparison of operative times for rTAPP
Measured: Minutes, up to 4 hours
Secondary outcomes (2)
Short-term complications
Evaluation of short term complications
Measured: 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
Measured: until 30 days after the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2023
- Primary completion7 Feb 2025
- Study completion7 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Muysoms, Algemeen Ziekenhuis Maria Middelares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599515
- Sponsor's protocol ID
- SUSHI
- Acronym
- SUSHI
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocenter Comparative Prospective Observational Cohort Study About Robot-assisted Laparoscopic Inguinal Hernia Repair Using Two Different Robotic Systems
- ClinicalTrials.gov ID
- NCT06599515
- Acronym / sponsor ID
- SUSHI / SUSHI
- Conditions
- Inguinal Hernia
- Keywords
- robot-assisted laparoscopic inguinal hernia repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HugoTM Ras (Medtronic) robotic system | – | Procedure: robotic surgical platformThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Recurrent hernias after previous preperitoneal mesh placement.
- Inguinal hernias after abdominal prostatectomy.
- Pregnancy.
- Emergency surgery.
- Age below 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| robotic surgical platformrobot-assisted laparoscopic inguinal hernia repair (rTAR) | Procedure or surgery | HugoTM Ras (Medtronic) robotic system |
Primary outcome
Operative times
Time frame: Minutes, up to 4 hours
Comparison of operative times for rTAPP
2 secondary outcomes
Short-term complications
Time frame: until 30 days after the surgical procedure
Quality of Life (QoL) one month after surgery
Time frame: until 30 days after the surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by Algemeen Ziekenhuis Maria Middelares at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative times (time frame: Minutes, up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.