Robotic Single Port Combined Umbilical and Inguinal Hernia Repair (CAPPUCCINOH)

August 20, 2026 updated by: Filip Muysoms, Algemeen Ziekenhuis Maria Middelares

Combined APProach of Umbilical ConComitant With Inguinal Hernia

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • East-Flanders
      • Ghent, East-Flanders, Belgium, 9000
        • Recruiting
        • AZ Maria Middelares
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair
Device: da Vinci Single Port Surgical System
Robotic surgical platform used to perform single-port robotic inguinal hernia repair with concomitant umbilical hernia repair through a single umbilical access site.
Procedure: Robotic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical errors with the robotic system
Time Frame: During surgery
Number and type of technical errors or device-related issues encountered during the procedure.
During surgery
Operative time
Time Frame: During surgery
Total operative time from skin incision to skin closure
During surgery
Complication Rate
Time Frame: From surgery until 1 month postoperatively
Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification
From surgery until 1 month postoperatively
Success rate
Time Frame: From surgery until planned follow-up 1 month potoperatively
success rate of preperitoneal mesh placement
From surgery until planned follow-up 1 month potoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Preoperatively, 1 month , and 1 year postoperatively
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 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
Preoperatively, 1 month and 1 year postoperatively
Number of Participants With Hernia Recurrence
Time Frame: 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.
1 year postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Algemeen Ziekenhuis Maria Middelares

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

August 5, 2026

First Submitted That Met QC Criteria

August 5, 2026

First Posted (Actual)

August 10, 2026

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CAPPUCCINOH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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