AZ Maria Middelares
Ghent, East-Flanders, 9000, Belgium
Location status: Recruiting
NCT Number: NCT07755696
Evaluation of the perioperative and patient reported outcomes of a new surgical technique: robotic inguinal hernia repair using the Da Vinci SP system.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Ghent, East-Flanders, 9000, Belgium
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: During surgery
Number and type of technical errors or device-related issues encountered during the procedure.
Time frame: During surgery
Total operative time from skin incision to skin closure
Time frame: From surgery until 1 month postoperatively
Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification
Time frame: From surgery until planned follow-up 1 month potoperatively
success rate of preperitoneal mesh placement
Time frame: Preoperatively, 1 month and 1 year postoperatively
Patient-reported quality of life assessed using the European Registry for Abdominal Wall Hernias (EuraHS) Quality of Life questionnaire.
Time frame: 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
Time frame: 1 year postoperatively
Presence of recurrent hernia assessed clinically and confirmed by ultrasound when clinically indicated.
Contact information is provided by the study sponsor or research team.
Filip Muysoms, MD, PhD
CONTACT
Jolien Lansens, Sc
CONTACT
Algemeen Ziekenhuis Maria Middelares
Other
Combined APProach of Umbilical ConComitant With Inguinal Hernia
Acronym: CAPPUCCINOH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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