ClinicalTrials.gg
RecruitingNCT07755657ESPRESSOHUpdated Aug 21, 2026

Robotic Single Port Ventral Hernia Repair

An interventional study of SP2 eTEP and da Vinci Single Port Surgical System in Ventral Hernia Repair, sponsored by Algemeen Ziekenhuis Maria Middelares. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Algemeen Ziekenhuis Maria Middelares · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Mar 2026, registered Aug 2026).
  • Started Mar 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 17 studies in Hernia, Ventral with a site in Belgium — 3 open to participants now, 4 under way, none of them phase 3. Hernia, Ventral · Belgium.

Planned enrollment
10th of 12
30 · median 98
Started
2026
with 1 other
No phase
12 of 17
2 open now
Registered
17th of 17
by date
Lead sponsor
4 of 17
Algemeen Ziekenhuis Maria Middelares

Among the 17 studies in Hernia, Ventral with a site in Belgium, this one is the 10th largest by planned enrollment of the 12 interventional ones that give a count, is one of 2 that started in 2026, is one of 12 with no phase, and was the 17th registered.

Hernia, Ventral

230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.

Browse Hernia, Ventral studies →

Open to participants now

3 of the 17 studies in Hernia, Ventral with a site in Belgium are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →

Who these studies take

Of the 26 Hernia, Ventral studies recruiting now, 19 (73%) set no upper age limit and 4 (15%) stop at 75 or younger; 1 take children under 18; 6 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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.

03

Conditions studied

  • Ventral Hernia Repair

Browse trials for

Keywords

  • Ventral hernia repair
  • da Vinci SP Surgical System
  • Extraperitoneal
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Post-prostatectomy
  • Post-preperitoneal mesh operation for inguinal hernia
  • Laparotomy in the lower abdomen
  • Caesarean section
  • Pregnancy
  • for general anaesthesia
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Robotic Suprapubic Ventral Hernia Repair (SP2 eTEP)

    Procedure: SP2 eTEP · Device: da Vinci Single Port Surgical System

Interventions

  • ProcedureSP2 eTEP

    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.

  • Deviceda Vinci Single Port Surgical System

    Robotic surgical platform used to perform the SP2 eTEP ventral hernia repair procedure through a single suprapubic incision.

06

What researchers measure

Primary outcomes

  1. Operative Time

    Duration of the robotic suprapubic ventral hernia repair procedure.

    Time frame: During surgery

  2. Technical Errors With the Robotic System

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

    Time frame: During surgery

  3. Complication Rate

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

    Time frame: From surgery until 1 month postoperatively

Secondary outcomes

  1. 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.

    Time frame: Preoperatively, 1 month and 1 year postoperatively

  2. 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.

    Time frame: Preoperatively, 1 month postoperatively, and 1 year postoperatively

  3. Hernia Recurrence Rate

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

    Time frame: 1 year postoperatively

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Dec 2027, 21 months after the start.

Of 75 non-industry interventional studies with no phase under Hernia, Ventral, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 48. This study's planned 21 months is below that.

Counting every sponsor, half of 88 studies reached it within 37 months; a quarter within 19 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2026
First posted
Aug 10, 2026
StartActual
Mar 11, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07755657
Lead sponsor
Algemeen Ziekenhuis Maria Middelares
Responsible party
Filip Muysoms (Head of Surgery Department, Algemeen Ziekenhuis Maria Middelares) — Principal investigator
First posted
Aug 10, 2026
Start date
Mar 11, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 21, 2026

Study contacts

Filip Muysoms, MD, PhD
Contact
filip.muysoms@gmail.com
+32477325710
Filip Muysoms, MD, PhD
principal investigator · Algemeen Ziekenhuis Maria Middelares

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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