Inguinal Hernia Repair, Umbilical Hernia Repair
Conditions
Keywords
Inguinal hernia repair, da Vinci SP Surgical System, concomitant umbilical hernia
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.
Interventions
Robotic surgical platform used to perform single-port robotic inguinal hernia repair with concomitant umbilical hernia repair through a single umbilical access site.
PROCEDURERobotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair
Robotic single-port inguinal hernia repair with concomitant umbilical hernia repair through a single umbilical access site using the da Vinci SP system.
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, 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical errors with the robotic system | During surgery | Number and type of technical errors or device-related issues encountered during the procedure. |
| Operative time | During surgery | Total operative time from skin incision to skin closure |
| Complication Rate | From surgery until 1 month postoperatively | Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification |
| Success rate | From surgery until planned follow-up 1 month potoperatively | success rate of preperitoneal mesh placement |
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 |
| Number of Participants With Hernia Recurrence | 1 year postoperatively | 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. |
Countries
Belgium
Contacts
CONTACTFilip Muysoms, MD, PhD
CONTACTJolien Lansens, Sc
Outcome results
None listed