Inguinal Hernia Repair
Conditions
Keywords
Inguinal hernia repair, da Vinci SP Surgical System, Suprapubic inguinal hernia repair
Brief summary
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.
Interventions
PROCEDUREsingle-port robotic suprapubic inguinal hernia repair
single-port robotic suprapubic inguinal hernia repair
Sponsors
Algemeen Ziekenhuis Maria Middelares
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | During surgery | Total operative time from skin incision to skin closure |
| Technical errors with the robotic system | During surgery | Number and type of technical errors or device-related issues encountered during the procedure. |
| Complication Rate | From surgery until 1 month postoperatively | Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EuraHS Quality of Life score | 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. |
| Body Image Questionnaire Score | 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 |
| hernia recurrence | 1 year postoperatively | Presence of recurrent hernia assessed clinically and confirmed by ultrasound when clinically indicated. |
Countries
Belgium
Contacts
CONTACTFilip Muysoms, MD, PhD
CONTACTJolien Lansens, Study coordinator
Outcome results
None listed