ClinicalTrials.gg
RecruitingNCT07756749MACCHIATOHUpdated Sep 4, 2026

Minimal ACCess Hernia InguinAlis Treatment of Hernia

An interventional study of single-port robotic suprapubic inguinal hernia repair in Inguinal Hernia Repair, sponsored by Algemeen Ziekenhuis Maria Middelares. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Algemeen Ziekenhuis Maria Middelares · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Inguinal Hernia Repair

Browse trials for

Keywords

  • Inguinal hernia repair
  • da Vinci SP Surgical System
  • Suprapubic inguinal hernia repair
03

In context

Hernia, Inguinal

543 studies on the registry are indexed under Hernia, Inguinal; 92 are open to participants now.

This study's planned enrollment of 30 is below the median of 90 across 395 interventional studies indexed under Hernia, Inguinal.

Browse Hernia, Inguinal studies →

Lead sponsor

Algemeen Ziekenhuis Maria Middelares is the lead sponsor of 37 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults with a primary inguinal hernia, either unilateral or bilateral

Exclusion criteria

Exclusion Criteria:

  • Recurrent inguinal hernia after preperitoneal repair
  • Irreducible scrotal hernia
  • Post-prostatectomy
  • Laparotomy in the lower abdomen
  • Pregnancy
  • for general anaesthesia
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    single-port robotic suprapubic inguinal hernia repair

    Procedure: single-port robotic suprapubic inguinal hernia repair

Interventions

  • Proceduresingle-port robotic suprapubic inguinal hernia repair

    single-port robotic suprapubic inguinal hernia repair

06

What researchers measure

Primary outcomes

  1. Operative time

    Total operative time from skin incision to skin closure

    Time frame: During surgery

  2. Technical errors with the robotic system

    Number and type of technical errors or device-related issues encountered during the procedure.

    Time frame: During surgery

  3. Complication Rate

    Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification

    Time frame: From surgery until 1 month postoperatively

Secondary outcomes

  1. 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.

    Time frame: Preoperatively, 1 month and 1 year postoperatively

  2. 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

    Time frame: Preoperatively, 1 month , and 1 year postoperatively

  3. hernia recurrence

    Presence of recurrent hernia assessed clinically and confirmed by ultrasound when clinically indicated.

    Time frame: 1 year postoperatively

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07756749
Lead sponsor
Algemeen Ziekenhuis Maria Middelares
Responsible party
Filip Muysoms (Head of Surgery Department, Algemeen Ziekenhuis Maria Middelares) — Principal investigator
First posted
Aug 11, 2026
Start date
Aug 2, 2026
Primary completion
Aug 2, 2028 (estimated)
Completion
Aug 1, 2029 (estimated)
Last update
Sep 4, 2026

Study contacts

Filip Muysoms, MD, PhD
Contact
filip.muysoms@gmail.com
+32477325710
Jolien Lansens, Study coordinator
Contact
Jolien.Lansens@mijnziekenhuis.be
+3292461854

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion