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NCT Number: NCT07756749

Minimal ACCess Hernia InguinAlis Treatment of Hernia

Evaluation of the perioperative and patient reported outcomes of a new surgical technique: single-port robotic suprapubic inguinal hernia repair (SPIN procedure).

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Key information

Conditions

Inguinal Hernia Repair

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Recurrent inguinal hernia after preperitoneal repair
  • Irreducible scrotal hernia
  • Post-prostatectomy
  • Laparotomy in the lower abdomen
  • Pregnancy
  • Contra-indication for general anaesthesia

Treatment and study plan

single-port robotic suprapubic inguinal hernia repair

Procedure

single-port robotic suprapubic inguinal hernia repair

Primary outcomes

  1. Operative time

    Time frame: During surgery

    Total operative time from skin incision to skin closure

  2. Technical errors with the robotic system

    Time frame: During surgery

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

  3. Complication Rate

    Time frame: From surgery until 1 month postoperatively

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

Secondary outcomes

  1. EuraHS Quality of Life score

    Time frame: Preoperatively, 1 month and 1 year postoperatively

    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.

  2. Body Image Questionnaire Score

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

    Patient-reported body image assessed using the Body Image Questionnaire. The questionnaire evaluates patient satisfaction with physical appearance and cosmetic outcomes

  3. hernia recurrence

    Time frame: 1 year postoperatively

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

Study contacts

Contact information is provided by the study sponsor or research team.

Filip Muysoms, MD, PhD

CONTACT

[email protected]

+32477325710

Jolien Lansens, Study coordinator

CONTACT

[email protected]

+3292461854

Sponsors and collaborators

Lead sponsor

Algemeen Ziekenhuis Maria Middelares

Other

Registry information

Official study title

Minimal ACCess Hernia InguinAlis Treatment of Hernia (MACCHIATOH Study): Prospective Cohort Study of Single-port Robotic Suprapubic Inguinal Hernia Repair (SPIN Procedure)

Acronym: MACCHIATOH

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 11, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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