Evaluation of SupraPubic Robotic Extraperitoneal Single-port Site Operation for Ventral Hernia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Operative Time
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Robotic Suprapubic Ventral Hernia Repair (SP2 eTEP)
Intervention: SP2 eTEP (Procedure)
Robotic Suprapubic Ventral Hernia Repair (SP2 eTEP)
Intervention: da Vinci Single Port Surgical System (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Body Image Questionnaire Score(Preoperatively, 1 month postoperatively, and 1 year postoperatively)
- Hernia Recurrence Rate(1 year postoperatively)
- EuraHS Quality of Life Score(Preoperatively, 1 month and 1 year postoperatively)
Investigators
Filip Muysoms
Head of Surgery Department
Algemeen Ziekenhuis Maria Middelares