Combined APProach of Umbilical ConComitant With Inguinal Hernia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Technical errors with the robotic system
Study Overview
Brief Summary
Evaluation of the perioperative and patient reported outcomes of a new surgical technique: robotic inguinal hernia repair using the Da Vinci SP system.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults with a primary inguinal hernia, either unilateral or bilateral, in association with a primary umbilical hernia of >1
Exclusion Criteria
- •recurrent inguinal hernia after preperitoneal repair
- •irreducible scrotal hernia
- •post-prostatectomy
- •laparotomy in the lower abdomen
- •pregnancy
- •contra-indication for general anaesthesia
Arms & Interventions
Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair
Intervention: Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair (Procedure)
Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair
Intervention: da Vinci Single Port Surgical System (Device)
Outcomes
Primary Outcomes
Technical errors with the robotic system
Time Frame: During surgery
Number and type of technical errors or device-related issues encountered during the procedure.
Operative time
Time Frame: During surgery
Total operative time from skin incision to skin closure
Complication Rate
Time Frame: From surgery until 1 month postoperatively
Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification
Success rate
Time Frame: From surgery until planned follow-up 1 month potoperatively
success rate of preperitoneal mesh placement
Secondary Outcomes
- Body Image Questionnaire Score(Preoperatively, 1 month , and 1 year postoperatively)
- EuraHS Quality of Life score(Preoperatively, 1 month and 1 year postoperatively)
- Number of Participants With Hernia Recurrence(1 year postoperatively)
Investigators
Filip Muysoms
Head of Surgery Department
Algemeen Ziekenhuis Maria Middelares