Inguinal Hernia RepairCAPPUCCINOHNCT07755696
Robotic Single Port Combined Umbilical and Inguinal Hernia Repair
A study testing da Vinci Single Port Surgical System and Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair in people with Inguinal Hernia Repair and Umbilical Hernia Repair, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
Trial summary
Evaluation of the perioperative and patient reported outcomes of a new surgical technique: robotic inguinal hernia repair using the Da Vinci SP system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia Repair, Umbilical Hernia Repair
- What is being tested?
- da Vinci Single Port Surgical System and Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2026to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with a primary inguinal hernia, either unilateral or bilateral, in association with a primary umbilical hernia of >1
Who cannot join
- recurrent inguinal hernia after preperitoneal repair
- irreducible scrotal hernia
- post-prostatectomy
- laparotomy in the lower abdomen
- pregnancy
- contra-indication for general anaesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
AZ Maria Middelares
Ghent, East-Flanders, 9000
Filip Muysoms, MD, PhD, +32477325710, filip.muysoms@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Inguinal Hernia Repair, Umbilical Hernia Repair
- Being tested
- da Vinci Single Port Surgical System, Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair
- Keywords
- Inguinal hernia repair, da Vinci SP Surgical System, concomitant umbilical hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
da Vinci Single Port Surgical SystemDevice
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 RepairProcedure or surgery
Robotic single-port inguinal hernia repair with concomitant umbilical hernia repair through a single umbilical access site using the da Vinci SP system.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair | Experimental | Not described Receives: Device: da Vinci Single Port Surgical System; Procedure: Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical errors with the robotic system
Number and type of technical errors or device-related issues encountered during the procedure.
Measured: During surgery
Operative time
Total operative time from skin incision to skin closure
Measured: During surgery
Complication Rate
Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification
Measured: From surgery until 1 month postoperatively
Success rate
success rate of preperitoneal mesh placement
Measured: From surgery until planned follow-up 1 month potoperatively
Secondary outcomes (3)
EuraHS Quality of Life score
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
Measured: Preoperatively, 1 month and 1 year postoperatively
Body Image Questionnaire Score
Patient-reported body image assessed using the Body Image Questionnaire. The questionnaire evaluates patient satisfaction with physical appearance and cosmetic outcomes
Measured: Preoperatively, 1 month , and 1 year postoperatively
Number of Participants With Hernia Recurrence
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.
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Apr 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Muysoms, Algemeen Ziekenhuis Maria Middelares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755696
- Sponsor's protocol ID
- CAPPUCCINOH
- Acronym
- CAPPUCCINOH
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined APProach of Umbilical ConComitant With Inguinal Hernia
- ClinicalTrials.gov ID
- NCT07755696
- Acronym / sponsor ID
- CAPPUCCINOH / CAPPUCCINOH
- Conditions
- Inguinal Hernia Repair, Umbilical Hernia Repair
- Keywords
- Inguinal hernia repair, da Vinci SP Surgical System, concomitant umbilical hernia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair | Experimental | Device: da Vinci Single Port Surgical System, Procedure: Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with a primary inguinal hernia, either unilateral or bilateral, in association with a primary umbilical hernia of >1
Key exclusion criteria (6 listed)
- recurrent inguinal hernia after preperitoneal repair
- irreducible scrotal hernia
- post-prostatectomy
- laparotomy in the lower abdomen
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| da Vinci Single Port Surgical SystemRobotic surgical platform used to perform single-port robotic inguinal hernia repair with concomitant umbilical hernia repair through a single umbilical access site. | Device | Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair |
| Robotic Single-Port Inguinal and Concomitant Umbilical Hernia RepairRobotic single-port inguinal hernia repair with concomitant umbilical hernia repair through a single umbilical access site using the da Vinci SP system. | Procedure or surgery | Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair |
Primary outcome
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
3 secondary outcomes
EuraHS Quality of Life score
Time frame: Preoperatively, 1 month and 1 year postoperatively
Body Image Questionnaire Score
Time frame: Preoperatively, 1 month , and 1 year postoperatively
Number of Participants With Hernia Recurrence
Time frame: 1 year postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing da Vinci Single Port Surgical System and Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair in people with Inguinal Hernia Repair and Umbilical Hernia Repair, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Filip Muysoms, MD, PhD (+32477325710, filip.muysoms@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical errors with the robotic system (time frame: During surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.