Evaluation of the perioperative and patient reported outcomes of a new surgical technique: single-port robotic suprapubic inguinal hernia repair (SPIN procedure).
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
single-port robotic suprapubic inguinal hernia repair
AZ Maria Middelares
Ghent, East-Flanders, Belgium
RECRUITINGOperative time
Total operative time from skin incision to skin closure
Time frame: During surgery
Technical errors with the robotic system
Number and type of technical errors or device-related issues encountered during the procedure.
Time frame: During surgery
Complication Rate
Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification
Time frame: From surgery until 1 month postoperatively
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
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
hernia recurrence
Presence of recurrent hernia assessed clinically and confirmed by ultrasound when clinically indicated.
Time frame: 1 year postoperatively
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