Evaluation of the perioperative and patient reported outcomes of a new surgical technique: robotic inguinal hernia repair using the Da Vinci SP system.
The CAPPUCCINOH study (Combined APProach of Umbilical ConComitant with Inguinal Hernia Repair) is a prospective single-centre, single-arm cohort study conducted at AZ Maria Middelares, Ghent, Belgium. The study evaluates a novel surgical technique combining robotic-assisted inguinal hernia repair with concomitant umbilical hernia repair using the da Vinci Single Port (SP) system. Building on the feasibility demonstrated in the ESPRITH study, the umbilical hernia defect is used as the single access site for the robotic procedure. Following inguinal hernia repair, the umbilical defect is repaired either by primary closure or with preperitoneal mesh reinforcement according to current guidelines and defect size. The primary objective is to assess the safety and feasibility of this approach by evaluating operative time, technical errors, successful mesh placement, and perioperative complications. Secondary objectives include assessment of patient-reported outcomes, quality of life, body image, and hernia recurrence at one year postoperatively. Patients will be followed for one year after surgery, with evaluations performed during hospitalization and at one month and one year postoperatively. The study aims to generate clinical evidence on the safety, effectiveness, and patient experience of robotic single-port repair for concomitant inguinal and umbilical hernias.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Robotic surgical platform used to perform single-port robotic inguinal hernia repair with concomitant umbilical hernia repair through a single umbilical access site.
Robotic single-port inguinal hernia repair with concomitant umbilical hernia repair through a single umbilical access site using the da Vinci SP system.
AZ Maria Middelares
Ghent, East-Flanders, Belgium
RECRUITINGTechnical errors with the robotic system
Number and type of technical errors or device-related issues encountered during the procedure.
Time frame: During surgery
Operative time
Total operative time from skin incision to skin closure
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
Success rate
success rate of preperitoneal mesh placement
Time frame: From surgery until planned follow-up 1 month potoperatively
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
Number of Participants With Hernia Recurrence
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Number of participants with a recurrent ventral hernia within 1 year after surgery. Hernia recurrence will be assessed clinically and confirmed by ultrasound when clinically indicated.
Time frame: 1 year postoperatively