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OpenTrials
Active, Not Recruiting

NCT Number: NCT07530159

Cost-Effectiveness of Retromuscular Hernia Repair

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ventral Hernia Repair

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Virgen del Rocío

Seville, Sevilla, 41013, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Length of hospital stay

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

Secondary outcomes

  1. Postoperative complications (Clavien-Dindo grade ≥ II)

    Time frame: Postoperative complications (Clavien-Dindo grade ≥ II) within 30 days

  2. Hernia recurrence

    Time frame: 12 months

  3. Health-related quality of life (EQ-5D-5L)

    Time frame: Health-related quality of life (EQ-5D-5L) at 6 and 12 months

    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.

  4. Cost-effectiveness (ICER)

    Time frame: Cost-effectiveness (ICER) at 12 months

  5. Postoperative pain (VAS)

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

    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

Sponsors and collaborators

Lead sponsor

Fátima Hinojosa Ramírez

Other

Registry information

Official study title

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

Acronym: ECOHERNIA-3

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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