Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07755696

Robotic Single Port Combined Umbilical and Inguinal Hernia Repair

Evaluation of the perioperative and patient reported outcomes of a new surgical technique: robotic inguinal hernia repair using the Da Vinci SP system.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Maria Middelares

Ghent, East-Flanders, 9000, Belgium

Location status: Recruiting

Location contact

Filip Muysoms, MD, PhD

CONTACT

[email protected]

+32477325710

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

da Vinci Single Port Surgical System

Device

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 and Concomitant Umbilical Hernia Repair

Procedure

Robotic single-port inguinal hernia repair with concomitant umbilical hernia repair through a single umbilical access site using the da Vinci SP system.

Primary outcomes

  1. Technical errors with the robotic system

    Time frame: During surgery

    Number and type of technical errors or device-related issues encountered during the procedure.

  2. Operative time

    Time frame: During surgery

    Total operative time from skin incision to skin closure

  3. Complication Rate

    Time frame: From surgery until 1 month postoperatively

    Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification

  4. Success rate

    Time frame: From surgery until planned follow-up 1 month potoperatively

    success rate of preperitoneal mesh placement

Secondary outcomes

  1. EuraHS Quality of Life score

    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.

  2. Body Image Questionnaire Score

    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

  3. Hernia recurrence

    Time frame: 1 year postoperatively

    Presence of recurrent hernia assessed clinically and confirmed by ultrasound when clinically indicated.

Study contacts

Contact information is provided by the study sponsor or research team.

Filip Muysoms, MD, PhD

CONTACT

[email protected]

+32477325710

Jolien Lansens, Sc

CONTACT

[email protected]

+3292461854

Sponsors and collaborators

Lead sponsor

Algemeen Ziekenhuis Maria Middelares

Other

Registry information

Official study title

Combined APProach of Umbilical ConComitant With Inguinal Hernia

Acronym: CAPPUCCINOH

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

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.

Published trials that share one or more normalized conditions with this study.