An interventional study of da Vinci Single Port Surgical System and Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair in Inguinal Hernia Repair and Umbilical 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 2026-08-21.
Sponsored by Algemeen Ziekenhuis Maria Middelares · Not applicable, Interventional, and Treatment
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.
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 →Algemeen Ziekenhuis Maria Middelares is the lead sponsor of 37 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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Contraindication
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Device: da Vinci Single Port Surgical System · Procedure: Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair
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.
Technical 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
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
Plan to share: No
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Algemeen Ziekenhuis Maria Middelares