Inguinal Hernia RepairMACCHIATOHNCT07756749
Minimal ACCess Hernia InguinAlis Treatment of Hernia
A study testing single-port robotic suprapubic inguinal hernia repair in people with Inguinal Hernia Repair, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
Trial summary
Evaluation of the perioperative and patient reported outcomes of a new surgical technique: single-port robotic suprapubic inguinal hernia repair (SPIN procedure). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia Repair
- What is being tested?
- single-port robotic suprapubic inguinal hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Aug 2026to 1 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with a primary inguinal hernia, either unilateral or bilateral
Who cannot join
- Recurrent inguinal hernia after preperitoneal repair
- Irreducible scrotal hernia
- Post-prostatectomy
- Laparotomy in the lower abdomen
- Pregnancy
- Contra-indication for general anaesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
AZ Maria Middelares
Ghent, East-Flanders, 9000
Filip Muysoms, MD, PhD, +32477325710, filip.muysoms@gmail.com
About this study
Official title: Minimal ACCess Hernia InguinAlis Treatment of Hernia (MACCHIATOH Study): Prospective Cohort Study of Single-port Robotic Suprapubic Inguinal Hernia Repair (SPIN Procedure)
Evaluation of the perioperative and patient reported outcomes of a new surgical technique: single-port robotic suprapubic inguinal hernia repair (SPIN procedure).
Read the detailed description
The MACCHIATOH study (Minimal ACCess Hernia InguinAlis Treatment of Hernia) is a prospective, single-centre, single-arm IDEAL Stage 2b cohort study conducted at AZ Maria Middelares (Ghent, Belgium). The study evaluates a novel single-port robotic suprapubic inguinal hernia repair technique (SPIN procedure) in a consecutive series of 30 patients undergoing primary inguinal hernia repair.
The SPIN procedure was developed to overcome some limitations of previously described single-port robotic approaches by using a suprapubic access route, which may provide improved access to the myopectineal orifice and potentially reduce the risk of access-site incisional hernias.
The study hypothesizes that the SPIN procedure is a safe and efficient technique without increased complication risk and may result in less postoperative pain, improved cosmetic outcomes, and equal or better patient satisfaction compared with current minimally invasive approaches. Patients will be followed for 12 months postoperatively.
- Conditions
- Inguinal Hernia Repair
- Being tested
- single-port robotic suprapubic inguinal hernia repair
- Keywords
- Inguinal hernia repair, da Vinci SP Surgical System, Suprapubic inguinal hernia repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-port robotic suprapubic inguinal hernia repairProcedure or surgery
single-port robotic suprapubic inguinal hernia repair
| Study group | Role | What they receive |
|---|---|---|
| single-port robotic suprapubic inguinal hernia repair | Experimental | Not described Receives: Procedure: single-port robotic suprapubic inguinal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Total operative time from skin incision to skin closure
Measured: During surgery
Technical errors with the robotic system
Number and type of technical errors or device-related issues encountered during the procedure.
Measured: During surgery
Complication Rate
Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification
Measured: From surgery until 1 month postoperatively
Secondary outcomes (3)
EuraHS Quality of Life score
Patient-reported quality of life assessed using the European Registry for Abdominal Wall Hernias Quality of Life (EuraHS-QoL) Questionnaire, a validated instrument evaluating pain at the hernia site, restriction of activities, and cosmetic discomfort. The total EuraHS-QoL score ranges from 0 to 90, with lower scores indicating better quality of life and less symptom burden, and higher scores indicating worse quality of life and greater symptom burden.
Measured: Preoperatively, 1 month and 1 year postoperatively
Body Image Questionnaire Score
Patient-reported body image assessed using the Body Image Questionnaire. The questionnaire evaluates patient satisfaction with physical appearance and cosmetic outcomes
Measured: Preoperatively, 1 month , and 1 year postoperatively
hernia recurrence
Presence of recurrent hernia assessed clinically and confirmed by ultrasound when clinically indicated.
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start2 Aug 2026
- Primary completion2 Aug 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia RepairStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
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
- NCT07756749
- Sponsor's protocol ID
- MACCHIATOH
- Acronym
- MACCHIATOH
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2026
- Last updated
- 4 Sep 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal ACCess Hernia InguinAlis Treatment of Hernia (MACCHIATOH Study): Prospective Cohort Study of Single-port Robotic Suprapubic Inguinal Hernia Repair (SPIN Procedure)
- ClinicalTrials.gov ID
- NCT07756749
- Acronym / sponsor ID
- MACCHIATOH / MACCHIATOH
- Conditions
- Inguinal Hernia Repair
- Keywords
- Inguinal hernia repair, da Vinci SP Surgical System, Suprapubic inguinal hernia repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- 2 Aug 2026 (actual)
- Primary completion
- 2 Aug 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 11 Aug 2026 (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.
Evaluation of the perioperative and patient reported outcomes of a new surgical technique: single-port robotic suprapubic inguinal hernia repair (SPIN procedure).
Detailed description
The MACCHIATOH study (Minimal ACCess Hernia InguinAlis Treatment of Hernia) is a prospective, single-centre, single-arm IDEAL Stage 2b cohort study conducted at AZ Maria Middelares (Ghent, Belgium). The study evaluates a novel single-port robotic suprapubic inguinal hernia repair technique (SPIN procedure) in a consecutive series of 30 patients undergoing primary inguinal hernia repair.
The SPIN procedure was developed to overcome some limitations of previously described single-port robotic approaches by using a suprapubic access route, which may provide improved access to the myopectineal orifice and potentially reduce the risk of access-site incisional hernias.
The study hypothesizes that the SPIN procedure is a safe and efficient technique without increased complication risk and may result in less postoperative pain, improved cosmetic outcomes, and equal or better patient satisfaction compared with current minimally invasive approaches. Patients will be followed for 12 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-port robotic suprapubic inguinal hernia repair | Experimental | Procedure: single-port robotic suprapubic inguinal hernia repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with a primary inguinal hernia, either unilateral or bilateral
Key exclusion criteria (6 listed)
- Recurrent inguinal hernia after preperitoneal repair
- Irreducible scrotal hernia
- Post-prostatectomy
- Laparotomy in the lower abdomen
- Pregnancy
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 |
|---|---|---|
| single-port robotic suprapubic inguinal hernia repairsingle-port robotic suprapubic inguinal hernia repair | Procedure or surgery | single-port robotic suprapubic inguinal hernia repair |
Primary outcome
Operative time
Time frame: During surgery
Total operative time from skin incision to skin closure
Technical errors with the robotic system
Time frame: During surgery
Number and type of technical errors or device-related issues encountered during the procedure.
Complication Rate
Time frame: From surgery until 1 month postoperatively
Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification
3 secondary outcomes
EuraHS Quality of Life score
Time frame: Preoperatively, 1 month and 1 year postoperatively
Body Image Questionnaire Score
Time frame: Preoperatively, 1 month , and 1 year postoperatively
hernia recurrence
Time frame: 1 year postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single-port robotic suprapubic inguinal hernia repair in people with Inguinal Hernia Repair, run by Algemeen Ziekenhuis Maria Middelares at 1 site 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 1 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Filip Muysoms, MD, PhD (+32477325710, filip.muysoms@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: During surgery). The study lists 3 primary outcomes in all. 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 4 Sep 2026.