Cost-Effectiveness of Retromuscular Hernia Repair (ECOHERNIA-3)

Cost-Effectiveness of Retromuscular Ventral Hernia Repair: Open, Laparoscopic and Robotic Approaches

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ventral Hernia Repair
• Intervention / Treatment: Procedure: Retromuscular ventral hernia repair; Device: Polypropylene mesh; Other: Standard perioperative care

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Sevilla
    • Seville, Sevilla, Spain, 41013
      • Hospital Universitario Virgen del Rocio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults ≥ 18 years
• Patients scheduled for elective retromuscular repair of midline ventral hernia
• Primary hernia or recurrent hernia without previous retromuscular repair
• Hernia defect width between 5 and 12 cm (EHS W2-W3)
• Ability to understand the study and provide informed consent

Exclusion Criteria:

• Contraindication to general anesthesia
• Contraindication to minimally invasive or open surgery
• Body mass index (BMI) > 35 kg/m²
• ASA physical status > IV
• Previous retromuscular hernia repair
• Lateral or parastomal hernias
• Emergency surgery
• Advanced disease with life expectancy < 2 years
• Pregnancy or planned pregnancy during follow-up
• Conditions significantly affecting wound healing or surgical risk (e.g., severe immunosuppression, active chemotherapy, connective tissue disorders)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open retromuscular repair; Patients undergoing open retromuscular midline ventral hernia repair acording to routine clinical practice	Procedure: Retromuscular ventral hernia repair; 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.; Device: Polypropylene mesh; Retromuscular transabdominal hernia repair with polypropylene mesh of 30x30 cm; Other: Standard perioperative care; Standard perioperative care including anesthesia, antibiotic prophylaxis, thromboprophylaxis, postoperative analgesia and routine postoperative management according to institutional protocols.
Experimental: Laparoscopic retromuscular repair; Patients undergoing laparoscopic retromuscular midline ventral hernia repair acording to routine clinical practice	Procedure: Retromuscular ventral hernia repair; 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.; Device: Polypropylene mesh; Retromuscular transabdominal hernia repair with polypropylene mesh of 30x30 cm; Other: Standard perioperative care; Standard perioperative care including anesthesia, antibiotic prophylaxis, thromboprophylaxis, postoperative analgesia and routine postoperative management according to institutional protocols.
Experimental: Robotic retromuscular repair; Patients undergoing robotic retromuscular midline ventral hernia repair acording to routine clinical practice	Procedure: Retromuscular ventral hernia repair; 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.; Device: Polypropylene mesh; Retromuscular transabdominal hernia repair with polypropylene mesh of 30x30 cm; Other: Standard perioperative care; Standard perioperative care including anesthesia, antibiotic prophylaxis, thromboprophylaxis, postoperative analgesia and routine postoperative management according to institutional protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Length of hospital stay	From date of surgery until hospital discharge (typically within 30 days postoperative)

Secondary Outcome Measures

Outcome Measure	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)	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)

Collaborators and Investigators

• Sponsor: Fátima Hinojosa Ramírez

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SICEIA-2025-002057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No