Robotic Single Port Ventral Hernia Repair

NCT07755657 | Recruiting

• 1 other identifier: ESPRESSOH
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ventral Hernia Repair

Keywords

Ventral hernia repair; da Vinci SP Surgical System; Extraperitoneal

Outcome Measures

Primary Outcomes (3)

• Operative Time

  Duration of the robotic suprapubic ventral hernia repair procedure.

  During surgery

• Technical Errors With the Robotic System

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

  During surgery

• Complication Rate

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

  From surgery until 1 month postoperatively

Secondary Outcomes (3)

• EuraHS Quality of Life Score

  Preoperatively, 1 month and 1 year postoperatively

• Body Image Questionnaire Score

  Preoperatively, 1 month postoperatively, and 1 year postoperatively

• Hernia Recurrence Rate

  1 year postoperatively

Study Arms (1)

Robotic Suprapubic Ventral Hernia Repair (SP2 eTEP)

EXPERIMENTAL

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

Interventions

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.

Robotic Suprapubic Ventral Hernia Repair (SP2 eTEP)

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.

Robotic Suprapubic Ventral Hernia Repair (SP2 eTEP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Algemeen Ziekenhuis Maria Middelares: lead

Study Sites (1)

AZ Maria Middelares

Ghent, East-Flanders, 9000, Belgium

RECRUITING

Study Officials

• Filip Muysoms, MD, PhD

  Algemeen Ziekenhuis Maria Middelares

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Filip Muysoms, MD, PhD

CONTACT

+32477325710; filip.muysoms@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Surgery Department

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)