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

April 8, 2026 updated by: Fátima Hinojosa Ramírez

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Length of hospital stay
Time Frame: From date of surgery until hospital discharge (typically within 30 days postoperative)
From date of surgery until hospital discharge (typically within 30 days postoperative)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative complications (Clavien-Dindo grade ≥ II)
Time Frame: Postoperative complications (Clavien-Dindo grade ≥ II) within 30 days
Postoperative complications (Clavien-Dindo grade ≥ II) within 30 days
Hernia recurrence
Time Frame: 12 months
12 months
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.
Health-related quality of life (EQ-5D-5L) at 6 and 12 months
Cost-effectiveness (ICER)
Time Frame: Cost-effectiveness (ICER) at 12 months
Cost-effectiveness (ICER) at 12 months
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
Postoperative pain (VAS) at 24 hours postoperatively and at hospital discharge (within 30 days after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fátima Hinojosa Ramírez

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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