Ventral Hernia RepairESPRESSOHNCT07755657
Robotic Single Port Ventral Hernia Repair
A study testing SP2 eTEP and da Vinci Single Port Surgical System in people with Ventral Hernia Repair, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
Trial summary
Evaluation of the perioperative outcomes of robotic suprapubic ventral hernia repair with the Da Vinci Singe Port (SP) system Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia Repair
- What is being tested?
- SP2 eTEP and da Vinci Single Port Surgical System
- 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
- 11 Mar 2026to 31 Dec 2027
- 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 midline ventral (umbilical or epigastric) classified as M1-M4 according to EHS classification with or without concomitant diastasis of the rectus abdominis muscles
Who cannot join
- Post-prostatectomy
- Post-preperitoneal mesh operation for inguinal hernia
- Laparotomy in the lower abdomen
- Caesarean section
- 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@azmmsj.be
About this study
Official title: Evaluation of SupraPubic Robotic Extraperitoneal Single-port Site Operation for Ventral Hernia
Evaluation of the perioperative outcomes of robotic suprapubic ventral hernia repair with the Da Vinci Singe Port (SP) system
Read the detailed description
Ventral hernia repair using mesh reinforcement is recommended for primary ventral hernias larger than 1 cm. Robotic-assisted techniques may facilitate extraperitoneal mesh placement and improve surgical precision. The da Vinci Single Port (SP) system enables robotic surgery through a single incision and may further reduce invasiveness while improving cosmetic outcomes.
The ESPRESSOH study is a single-centre, single-arm prospective cohort study evaluating a novel robotic suprapubic extraperitoneal single-port technique (SP2 eTEP) for ventral hernia repair, with or without concomitant diastasis repair. The study aims to assess perioperative outcomes, safety, technical feasibility, patient-reported quality of life and body image, and hernia recurrence following surgery performed with the da Vinci SP system. Participants will be followed for one year after surgery.
- Conditions
- Ventral Hernia Repair
- Being tested
- SP2 eTEP, da Vinci Single Port Surgical System
- Keywords
- Ventral hernia repair, da Vinci SP Surgical System, Extraperitoneal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP2 eTEPProcedure or surgery
Participants undergo robotic suprapubic ventral hernia repair using the SP2 eTEP (suprapubic extraperitoneal single-port enhanced-view totally extraperitoneal) technique with the da Vinci Single Port surgical system. The procedure includes extraperitoneal mesh placement for repair of primary ventral hernias, with or without concomitant diastasis repair.
da Vinci Single Port Surgical SystemDevice
Robotic surgical platform used to perform the SP2 eTEP ventral hernia repair procedure through a single suprapubic incision.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Suprapubic Ventral Hernia Repair (SP2 eTEP) | Experimental | Not described Receives: Procedure: SP2 eTEP; Device: da Vinci Single Port Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
Duration of the robotic suprapubic ventral hernia repair procedure.
Measured: During surgery
Technical Errors With the Robotic System
Number and type of technical errors or device-related issues encountered during the procedure.
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
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 following robotic ventral hernia repair.
Measured: Preoperatively, 1 month postoperatively, and 1 year postoperatively
Hernia Recurrence Rate
Presence of recurrent ventral hernia 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 start11 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral 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
- Investigators
- Filip Muysoms, MD, PhD, Principal investigator, Algemeen Ziekenhuis Maria Middelares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755657
- Sponsor's protocol ID
- ESPRESSOH
- Acronym
- ESPRESSOH
- 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
- Evaluation of SupraPubic Robotic Extraperitoneal Single-port Site Operation for Ventral Hernia
- ClinicalTrials.gov ID
- NCT07755657
- Acronym / sponsor ID
- ESPRESSOH / ESPRESSOH
- Conditions
- Ventral Hernia Repair
- Keywords
- Ventral hernia repair, da Vinci SP Surgical System, Extraperitoneal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (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 outcomes of robotic suprapubic ventral hernia repair with the Da Vinci Singe Port (SP) system
Detailed description
Ventral hernia repair using mesh reinforcement is recommended for primary ventral hernias larger than 1 cm. Robotic-assisted techniques may facilitate extraperitoneal mesh placement and improve surgical precision. The da Vinci Single Port (SP) system enables robotic surgery through a single incision and may further reduce invasiveness while improving cosmetic outcomes.
The ESPRESSOH study is a single-centre, single-arm prospective cohort study evaluating a novel robotic suprapubic extraperitoneal single-port technique (SP2 eTEP) for ventral hernia repair, with or without concomitant diastasis repair. The study aims to assess perioperative outcomes, safety, technical feasibility, patient-reported quality of life and body image, and hernia recurrence following surgery performed with the da Vinci SP system. Participants will be followed for one year after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Suprapubic Ventral Hernia Repair (SP2 eTEP) | Experimental | Procedure: SP2 eTEP, Device: da Vinci Single Port Surgical System |
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 midline ventral (umbilical or epigastric) classified as M1-M4 according to EHS classification with or without concomitant diastasis of the rectus abdominis muscles
Key exclusion criteria (6 listed)
- Post-prostatectomy
- Post-preperitoneal mesh operation for inguinal hernia
- Laparotomy in the lower abdomen
- Caesarean section
- 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 |
|---|---|---|
| SP2 eTEPParticipants undergo robotic suprapubic ventral hernia repair using the SP2 eTEP (suprapubic extraperitoneal single-port enhanced-view totally extraperitoneal) technique with the da Vinci Single Port surgical system. The procedure includes extraperitoneal mesh placement for repair of primary ventral hernias, with or without concomitant diastasis repair. | Procedure or surgery | Robotic Suprapubic Ventral Hernia Repair (SP2 eTEP) |
| da Vinci Single Port Surgical SystemRobotic surgical platform used to perform the SP2 eTEP ventral hernia repair procedure through a single suprapubic incision. | Device | Robotic Suprapubic Ventral Hernia Repair (SP2 eTEP) |
Primary outcome
Operative Time
Time frame: During surgery
Duration of the robotic suprapubic ventral hernia repair procedure.
Technical Errors With the Robotic System
Time frame: During surgery
Number and type of technical errors or device-related issues encountered during the procedure.
Complication Rate
Time frame: From surgery until 1 month postoperatively
Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification.
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 postoperatively, and 1 year postoperatively
Hernia Recurrence Rate
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.
Filip Muysoms, MD, PhD principal investigator
Algemeen Ziekenhuis Maria Middelares
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SP2 eTEP and da Vinci Single Port Surgical System in people with Ventral 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?
Operative Time (time frame: During surgery). The study lists 3 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.