Ventral Hernia RepairECOHERNIA-3NCT07530159
Cost-Effectiveness of Retromuscular Hernia Repair
A study testing Retromuscular ventral hernia repair, Polypropylene mesh and Standard perioperative care in people with Ventral Hernia Repair, run by Fátima Hinojosa Ramírez at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia Repair
- What is being tested?
- Retromuscular ventral hernia repair, Polypropylene mesh and Standard perioperative care
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Ventral Hernia Repair
- Being tested
- Retromuscular ventral hernia repair, Polypropylene mesh, Standard perioperative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retromuscular ventral hernia repairProcedure or surgery
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 meshDevice
Retromuscular transabdominal hernia repair with polypropylene mesh of 30x30 cm
Standard perioperative careOther
Standard perioperative care including anesthesia, antibiotic prophylaxis, thromboprophylaxis, postoperative analgesia and routine postoperative management according to institutional protocols.
| Study group | Role | What they receive |
|---|---|---|
| Open retromuscular repair | Active comparator | Patients undergoing open retromuscular midline ventral hernia repair acording to routine clinical practice Receives: 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 Receives: 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 Receives: Procedure: Retromuscular ventral hernia repair; Device: Polypropylene mesh; Other: Standard perioperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Measured: From date of surgery until hospital discharge (typically within 30 days postoperative)
Secondary outcomes (5)
Postoperative complications (Clavien-Dindo grade ≥ II)
Measured: Postoperative complications (Clavien-Dindo grade ≥ II) within 30 days
Hernia recurrence
Measured: 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.
Measured: Health-related quality of life (EQ-5D-5L) at 6 and 12 months
Cost-effectiveness (ICER)
Measured: 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
Measured: Postoperative pain (VAS) at 24 hours postoperatively and at hospital discharge (within 30 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral Hernia RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fátima Hinojosa Ramírez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fátima Hinojosa Ramírez, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530159
- Sponsor's protocol ID
- SICEIA-2025-002057
- Acronym
- ECOHERNIA-3
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Effectiveness of Retromuscular Ventral Hernia Repair: Open, Laparoscopic and Robotic Approaches
- ClinicalTrials.gov ID
- NCT07530159
- Acronym / sponsor ID
- ECOHERNIA-3 / SICEIA-2025-002057
- Conditions
- Ventral Hernia Repair
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fátima Hinojosa RamírezUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open retromuscular repair | Active comparator | Procedure: Retromuscular ventral hernia repair, Device: Polypropylene mesh, Other: Standard perioperative carePatients undergoing open retromuscular midline ventral hernia repair acording to routine clinical practice |
| Laparoscopic retromuscular repair | Experimental | Procedure: Retromuscular ventral hernia repair, Device: Polypropylene mesh, Other: Standard perioperative carePatients undergoing laparoscopic retromuscular midline ventral hernia repair acording to routine clinical practice |
| Robotic retromuscular repair | Experimental | Procedure: Retromuscular ventral hernia repair, Device: Polypropylene mesh, Other: Standard perioperative carePatients undergoing robotic retromuscular midline ventral hernia repair acording to routine clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retromuscular ventral hernia repairRetromuscular 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. | Procedure or surgery | Laparoscopic retromuscular repair, Open retromuscular repair, Robotic retromuscular repair |
| Polypropylene meshRetromuscular transabdominal hernia repair with polypropylene mesh of 30x30 cm | Device | Laparoscopic retromuscular repair, Open retromuscular repair, Robotic retromuscular repair |
| Standard perioperative careStandard perioperative care including anesthesia, antibiotic prophylaxis, thromboprophylaxis, postoperative analgesia and routine postoperative management according to institutional protocols. | Other | Laparoscopic retromuscular repair, Open retromuscular repair, Robotic retromuscular repair |
Primary outcome
Length of hospital stay
Time frame: From date of surgery until hospital discharge (typically within 30 days postoperative)
5 secondary outcomes
Postoperative complications (Clavien-Dindo grade ≥ II)
Time frame: Postoperative complications (Clavien-Dindo grade ≥ II) within 30 days
Hernia recurrence
Time frame: 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
Cost-effectiveness (ICER)
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retromuscular ventral hernia repair, Polypropylene mesh and Standard perioperative care in people with Ventral Hernia Repair, run by Fátima Hinojosa Ramírez at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: From date of surgery until hospital discharge (typically within 30 days postoperative)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.