Minimally invasive laparoscopic and robotic repair for non-inguinal abdominal wall hernias

Prospective Study of Minimally Invasive Hernia Repair

This registry will follow adults having laparoscopic or robotic repair for abdominal wall hernias (not inguinal) for five years to see how well the operations work and what complications occur.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz (other)
• Locations: 1 site (Madrid, Madrid)
• Trial ID: NCT07544238 on ClinicalTrials.gov

What this trial studies

Researchers will prospectively register adults who consent and are scheduled for elective laparoscopic or robotic repair of abdominal wall hernias (excluding inguinal hernias) at a single center in Madrid. Treatment follows standard clinical practice and patients will be reviewed in person at 2–3 months, 1 year (with routine CT when indicated), 3 years and 5 years after surgery. The registry will collect data on hernia recurrence, intra- and postoperative complications, pain, quality of life, and esthetic outcome. Collected data will be used to describe long-term outcomes and complications after minimally invasive ventral hernia repair.

Who should consider this trial

Good fit: Adults scheduled for elective minimally invasive (laparoscopic or robotic) repair of non-inguinal abdominal wall hernias who meet the operating surgeon's criteria and can provide written informed consent.

Not a fit: Patients who are pregnant, who decline or cannot give written consent, who have hernias or comorbidities that preclude minimally invasive repair (for example loss of domain, giant hernias, very small W1 isolated midline hernias, or severe pulmonary or cardiac disease), or who have inguinal hernias are not eligible and will not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could give patients and surgeons clearer information about long-term recurrence, pain, cosmetic results, and complication rates after minimally invasive ventral hernia repair.

How similar studies have performed: Prior observational studies and randomized trials of laparoscopic and robotic ventral hernia repair have generally shown reduced wound complications and faster recovery versus open repair, but long-term recurrence rates are variable and extended registry data remain limited.

Eligibility criteria

Inclusion Criteria:

* Indication for elective minimally invasive ventral hernia repair due to criteria of the participating surgeons

Exclusion Criteria:

* 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)

Where this trial is running

Madrid, Madrid

• Hospital Universitario Fundacion Jiménez Díaz — Madrid, Madrid, Spain (RECRUITING)

Study contacts

• Study coordinator: Marius Kaeser, Doctors Degree

Conditions: Ventral Hernia Midline, Hernia Lumbar, Incisional Hernia Repair