Prospective Study of Minimally Invasive (Laparoscopic and Robotic) Hernia Repair (Incisional and Primary, Midline and Lateral, Not Inguinal) (PROMISER)

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Status: Enrolling

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

Treatments: Procedure: Minimally invasive hernioplastia

Study type: Observational

Funder types: Other

Identifiers

NCT07544238

PROMISER2026

Details and patient eligibility

About

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).

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

400 participants in 1 patient group

All adult patients with indication of elective minimally invasive abdominal wall hernia surgery

Description:

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

Treatment:

Procedure: Minimally invasive hernioplastia