Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This prospective observational study aims to evaluate the clinical outcomes and cost-effectiveness of retromuscular midline ventral hernia repair using open, laparoscopic and robotic approaches. Patients undergoing elective repair are included and followed to assess postoperative complications, length of hospital stay, recurrence and quality of life. In addition, a cost-effectiveness analysis will be performed from the perspective of the Spanish National Health System. The study is currently ongoing.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open retromuscular repair | Active Comparator | Patients undergoing open retromuscular midline ventral hernia repair acording to routine clinical practice |
|
| Laparoscopic retromuscular repair | Experimental | Patients undergoing laparoscopic retromuscular midline ventral hernia repair acording to routine clinical practice |
|
| Robotic retromuscular repair | Experimental | Patients undergoing robotic retromuscular midline ventral hernia repair acording to routine clinical practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retromuscular ventral hernia repair | Procedure | Retromuscular ventral hernia repair involves dissection of the retromuscular space, closure of the hernia defect and placement of a mesh in the retromuscular position. The procedure may be performed using an open, laparoscopic or robotic approach according to surgical practice. Differences between approaches relate to access, visualization and instrumentation, while maintaining the same anatomical plane of repair. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | From date of surgery until hospital discharge (typically within 30 days postoperative) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications (Clavien-Dindo grade ≥ II) | Postoperative complications (Clavien-Dindo grade ≥ II) within 30 days | |
| Hernia recurrence | 12 months | |
| Health-related quality of life (EQ-5D-5L) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del RocĂo | Seville | Sevilla | 41013 | Spain |
Individual participant data will not be publicly shared due to data protection regulations and institutional policies. Aggregated data may be available upon reasonable request to the corresponding author.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Polypropylene mesh | Device | Retromuscular transabdominal hernia repair with polypropylene mesh of 30x30 cm |
|
| Standard perioperative care | Other | Standard perioperative care including anesthesia, antibiotic prophylaxis, thromboprophylaxis, postoperative analgesia and routine postoperative management according to institutional protocols. |
|
Health-related quality of life measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L index ranges from values below 0 (worse than death) to 1 (full health), with higher scores indicating netter quality of life. |
| Health-related quality of life (EQ-5D-5L) at 6 and 12 months |
| Cost-effectiveness (ICER) | Cost-effectiveness (ICER) at 12 months |
| Postoperative pain (VAS) | Postoperative pain measured using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores including grater pain intensity | Postoperative pain (VAS) at 24 hours postoperatively and at hospital discharge (within 30 days after surgery) |