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NCT Number: NCT07755657

Robotic Single Port Ventral Hernia Repair

Evaluation of the perioperative outcomes of robotic suprapubic ventral hernia repair with the Da Vinci Singe Port (SP) system

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Key information

Conditions

Ventral Hernia Repair

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

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.

Who can participate

Healthy volunteers accepted: No

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

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

  • Post-prostatectomy
  • Post-preperitoneal mesh operation for inguinal hernia
  • Laparotomy in the lower abdomen
  • Caesarean section
  • Pregnancy
  • Contra-indication for general anaesthesia

Treatment and study plan

SP2 eTEP

Procedure

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 System

Device

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

Primary outcomes

  1. Operative Time

    Time frame: During surgery

    Duration of the robotic suprapubic ventral hernia repair procedure.

  2. Technical Errors With the Robotic System

    Time frame: During surgery

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

  3. Complication Rate

    Time frame: From surgery until 1 month postoperatively

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

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 postoperatively, 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 following robotic ventral hernia repair.

  3. Hernia Recurrence Rate

    Time frame: 1 year postoperatively

    Presence of recurrent ventral 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

Sponsors and collaborators

Lead sponsor

Algemeen Ziekenhuis Maria Middelares

Other

Registry information

Official study title

Evaluation of SupraPubic Robotic Extraperitoneal Single-port Site Operation for Ventral Hernia

Acronym: ESPRESSOH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
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.

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