Ventral Hernia Repair
Conditions
Keywords
Ventral hernia repair, da Vinci SP Surgical System, Extraperitoneal
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.
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.
Robotic surgical platform used to perform the SP2 eTEP ventral hernia repair procedure through a single suprapubic incision.
Sponsors
Algemeen Ziekenhuis Maria Middelares
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | During surgery | Duration of the robotic suprapubic ventral hernia repair procedure. |
| Technical Errors With the Robotic System | During surgery | Number and type of technical errors or device-related issues encountered during the procedure. |
| Complication Rate | From surgery until 1 month postoperatively | Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EuraHS Quality of Life Score | Preoperatively, 1 month and 1 year postoperatively | 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. |
| Body Image Questionnaire Score | 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. |
| Hernia Recurrence Rate | 1 year postoperatively | Presence of recurrent ventral hernia assessed clinically and confirmed by ultrasound when clinically indicated. |
Countries
Belgium
Contacts
CONTACTFilip Muysoms, MD, PhD
PRINCIPAL_INVESTIGATORFilip Muysoms, MD, PhD
Algemeen Ziekenhuis Maria Middelares
Outcome results
None listed