Ventral Hernia MidlinePROMISERNCT07544238
Prospective Study of Minimally Invasive (Laparoscopic and Robotic) Hernia Repair (Incisional and Primary, Midline and Lateral, Not Inguinal)
An observational study of Ventral Hernia Midline and Hernia Lumbar, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
The participating researchers register all adult patients (who have given informed written consent) scheduled for elective repair of an abdominal wall hernia (NOT inguinal hernias) via minimally invasive operation technique (i.e.: laparoscopy or robotic repair) and perform a follow up of 5 years to analyze clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia Midline, Hernia Lumbar, Incisional Hernia Repair
- What is being tested?
- Minimally invasive hernioplastia
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- 14 Apr 2026to 14 Apr 2036
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
Study population: All adults referred to our department presenting an abdominal wall hernia with surgical indication
Who may be able to join
- Indication for elective minimally invasive ventral hernia repair due to criteria of the participating surgeons
Who cannot join
- Patient rejects participation or giving written informed consent
- Positive pregnancy test (Beta HCG in serum)
- Patients who do not meet criteria for minimally invasive surgery due to the criteria of the including surgeon or anesthesiologist (Loss of domain, giant abdominal wall herniae, very small (W1) isolated midline hernia, severe pulmonary or cardiac pathologies)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Fundacion Jiménez Díaz
Madrid, Madrid, 28040
Marius Kaeser, Doctors Degree, 0034 915 50 48 00 ext. +4331, marius.kaser@quironsalud.es
About this study
Official title: Prospective Study of Minimally Invasive Hernia Repair
The participating researchers register all adult patients (who have given informed written consent) scheduled for elective repair of an abdominal wall hernia (NOT inguinal hernias) via minimally invasive operation technique (i.e.: laparoscopy or robotic repair) and perform a follow up of 5 years to analyze clinical outcome parameters. These parameters include recurrence of the hernia, intra- and postoperative complications, quality of live, esthetic outcome and pain.
The patients will be reviewed in person by the participating researchers at 2-3 moths, 1 year, 3 years and 5 years after surgery. A computed tomography will be performed at 1 year after surgery and in case of suspicion of complications, for example hernia recurrence. The treatment and follow-up of the participating patients does not differ from the standard treatment protocol (and the not participating patients).
- Being tested
- Minimally invasive hernioplastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive hernioplastiaProcedure or surgery
laparoscopic or robotically assisted hernioplastia
| Study group | Role | What they receive |
|---|---|---|
| All adult patients with indication of elective minimally invasive abdominal wall hernia surgery | The patients will be intervened by laparoscopic or robotically assisted hernioplastia of midline or lumbar hernias, either primary or secondary in nature. Inguinal hernias will only be included if they exist apart from the primarily targeted midline or lumbar abdominal wall hernia Receives: Procedure: Minimally invasive hernioplastia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia recurrence rate
Percentage of all the patients intervened who present a radiologically (via CAT Scan or MRI in case of contraindication for CAT Scan) confirmed hernia recurrence. In case of suspicion (physical exam and/or symptoms reported by the patient) a CAT Scan will be performed to confirm or discard the diagnosis, at any time of the follow-up
Measured: 5 years (the time to recurrence will be defined by the moment of radiological confirmation)
Secondary outcomes (9)
Postoperative complications Clavien Dindo
Registration of postoperative complications according to the Clavien Dindo Definition
Measured: 90 days after surgery
Surgical Site Occurrence (SSO)
Any alteration of postoperative wound healing (including surgical site infection, hematoma, seroma and wound dehiscence) and the required intervention (none, bedside intervention, radiologically guided intervention, surgery)
Measured: 5 years
Perioperative bleeding
Any drop in serum hemoglobin levels > 2 g/dl within 24 hours or > 3 g/dl compared to preoperative values or hemodynamically relevant bleeding or necessity for blood transfusion or surgical reintervention because of bleeding
Measured: 30 days
Mortality
Percentage of the total of registered patients who perish
Measured: 5 years
Hernia associated quality of life
Hernia associated quality of life assessed by the EuraHS QoL (European Registry for Abdominal Wall Hernias Quality of Life Questionnaire). The questionnaire contemplates 9 items, scoring them with values of 0-10. They are subgroups into 3 items assessing pain, 4 items assessing restriction of activities and 2 items assessing the cosmetic outcome as perceived by the patient. A higher score means is linked to a worse outcome. 0 points would be the best outcome, 90 points the worst outcome possible.
Measured: 5 years
Postoperative pain
Postoperative pain measured via VAS (Visual Analogue Scale, valued with 0-10 points, lower numbers relating to less pain, higher numbers to more pain, that is: a worse outcome)
Measured: 24 and 48 hours after surgery (during the rest of the follow-up this value is included in the EuraHS QoL questionnaire)
Reintervention Rate
Percentage of the total of registered patients with surgical reintervention due to complications of the performed surgery (hernia recurrence or others)
Measured: 5 years
Risk Factors
Descrition of the incidence of known risk factors for hernia formation at the time of surgery (Diabetes mellitus, arterial hypertension, dislipemia, anti aggregation, anticoagulation, pathologies of the connective tissues like Ehlers-Danlos or Marfan syndrome, abdominal aortic ectasia or aneurysm, cardiac pathologies, active malignant disease, chemotherapy within the last 3 months, active smoking, alcohol abuse, chronic liver disease
Measured: Only at time of inclusion
Prehabilitation
Description of the percentage of patients treated with either Botox injection into the abdominal wall within 8 weeks before surgery and / or pulmonary prehabilitation and / or included in a weight loss program before surgery and / or have canceled an existing smoking habit before surgery
Measured: at the time of registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start14 Apr 2026
- Primary completion14 Apr 2036 (estimated)
- Study completion14 Apr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral Hernia MidlineStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marius Kaeser, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544238
- Sponsor's protocol ID
- PROMISER2026
- Acronym
- PROMISER
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the raw data registered and relevant for the described primary and secondary outcomes, but NOT the personal details necessary to identify the person (birth date, name, medical record number). In essence: only the pseudonymized data is provided.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Minimally Invasive Hernia Repair
- ClinicalTrials.gov ID
- NCT07544238
- Acronym / sponsor ID
- PROMISER / PROMISER2026
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 14 Apr 2036 (estimated)
- Study completion
- 14 Apr 2036 (estimated)
- First posted
- 22 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.
The participating researchers register all adult patients (who have given informed written consent) scheduled for elective repair of an abdominal wall hernia (NOT inguinal hernias) via minimally invasive operation technique (i.e.: laparoscopy or robotic repair) and perform a follow up of 5 years to analyze clinical outcome parameters. These parameters include recurrence of the hernia, intra- and postoperative complications, quality of live, esthetic outcome and pain.
The patients will be reviewed in person by the participating researchers at 2-3 moths, 1 year, 3 years and 5 years after surgery. A computed tomography will be performed at 1 year after surgery and in case of suspicion of complications, for example hernia recurrence. The treatment and follow-up of the participating patients does not differ from the standard treatment protocol (and the not participating patients).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All adult patients with indication of elective minimally invasive abdominal wall hernia surgery | – | Procedure: Minimally invasive hernioplastiaThe patients will be intervened by laparoscopic or robotically assisted hernioplastia of midline or lumbar hernias, either primary or secondary in nature. Inguinal hernias will only be included if they exist apart from the primarily targeted midline or lumbar abdominal wall hernia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults referred to our department presenting an abdominal wall hernia with surgical indication
Key inclusion criteria (1 listed)
- Indication for elective minimally invasive ventral hernia repair due to criteria of the participating surgeons
Key exclusion criteria (3 listed)
- Patient rejects participation or giving written informed consent
- Positive pregnancy test (Beta HCG in serum)
- Patients who do not meet criteria for minimally invasive surgery due to the criteria of the including surgeon or anesthesiologist (Loss of domain, giant abdominal wall herniae, very small (W1) isolated midline hernia, severe pulmonary or cardiac pathologies)
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 |
|---|---|---|
| Minimally invasive hernioplastialaparoscopic or robotically assisted hernioplastia | Procedure or surgery | All adult patients with indication of elective minimally invasive abdominal wall hernia surgery |
Primary outcome
Hernia recurrence rate
Time frame: 5 years (the time to recurrence will be defined by the moment of radiological confirmation)
Percentage of all the patients intervened who present a radiologically (via CAT Scan or MRI in case of contraindication for CAT Scan) confirmed hernia recurrence. In case of suspicion (physical exam and/or symptoms reported by the patient) a CAT Scan will be performed to confirm or discard the diagnosis, at any time of the follow-up
9 secondary outcomes
Postoperative complications Clavien Dindo
Time frame: 90 days after surgery
Surgical Site Occurrence (SSO)
Time frame: 5 years
Perioperative bleeding
Time frame: 30 days
Mortality
Time frame: 5 years
Hernia associated quality of life
Time frame: 5 years
Postoperative pain
Time frame: 24 and 48 hours after surgery (during the rest of the follow-up this value is included in the EuraHS QoL questionnaire)
Reintervention Rate
Time frame: 5 years
Risk Factors
Time frame: Only at time of inclusion
Prehabilitation
Time frame: at the time of registration
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 27 Apr 2026.
- Individual participant dataSharing planned: Yes. All the raw data registered and relevant for the described primary and secondary outcomes, but NOT the personal details necessary to identify the person (birth date, name, medical record number). In essence: only the pseudonymized data is provided.
Related trials for Ventral Hernia Midline
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Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
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Enrolling by invitation
Shear-Wave Elastography
Ventral Incisional Hernia
Enrolling by invitationPhase 2
Preoperative Botulinum Toxin A to Facilitate Midline Closure in Large Chronic Ventral Hernias
Hernia
Recruiting
Open Vs. Endoscopic Transversus Abdominis Release Trial
Incisional Hernia of Midline of Abdomen
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventral Hernia Midline and Hernia Lumbar, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 27 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?
Contact Marius Kaeser, Doctors Degree (0034 915 50 48 00 ext. 4331, marius.kaser@quironsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia recurrence rate (time frame: 5 years (the time to recurrence will be defined by the moment of radiological confirmation)). 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 27 Apr 2026.