Cost-Effectiveness of Retromuscular Hernia Repair

NCT07530159 | Active Not Recruiting

• 1 other identifier: SICEIA-2025-002057
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventral Hernia Repair

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  From date of surgery until hospital discharge (typically within 30 days postoperative)

Secondary Outcomes (5)

• 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 (EQ-5D-5L) at 6 and 12 months

• Cost-effectiveness (ICER)

  Cost-effectiveness (ICER) at 12 months

• Postoperative pain (VAS)

  Postoperative pain (VAS) at 24 hours postoperatively and at hospital discharge (within 30 days after surgery)

Study Arms (3)

Open retromuscular repair

ACTIVE COMPARATOR

Patients undergoing open retromuscular midline ventral hernia repair acording to routine clinical practice

Procedure: Retromuscular ventral hernia repair; Device: Polypropylene mesh; Other: Standard perioperative care

Laparoscopic retromuscular repair

EXPERIMENTAL

Patients undergoing laparoscopic retromuscular midline ventral hernia repair acording to routine clinical practice

Procedure: Retromuscular ventral hernia repair; Device: Polypropylene mesh; Other: Standard perioperative care

Robotic retromuscular repair

EXPERIMENTAL

Patients undergoing robotic retromuscular midline ventral hernia repair acording to routine clinical practice

Procedure: Retromuscular ventral hernia repair; Device: Polypropylene mesh; Other: Standard perioperative care

Interventions

Polypropylene mesh DEVICE

Retromuscular transabdominal hernia repair with polypropylene mesh of 30x30 cm

Laparoscopic retromuscular repair; Open retromuscular repair; Robotic retromuscular repair

Standard perioperative care OTHER

Standard perioperative care including anesthesia, antibiotic prophylaxis, thromboprophylaxis, postoperative analgesia and routine postoperative management according to institutional protocols.

Laparoscopic retromuscular repair; Open retromuscular repair; Robotic retromuscular repair

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.

Laparoscopic retromuscular repair; Open retromuscular repair; Robotic retromuscular repair

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fátima Hinojosa Ramírez: lead

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, Sevilla, 41013, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator (Consultant Surgeon in General and Digestive Surgery)

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 15, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)