Prospective Study of Minimally Invasive (Laparoscopic and Robotic) Hernia Repair (Incisional and Primary, Midline and Lateral, Not Inguinal)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Minimally invasive hernioplastia.
- Who it may be relevant to
- Registry conditions: Ventral Hernia Midline, Hernia Lumbar, Incisional Hernia Repair. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Study of Minimally Invasive Hernia Repair
Overview
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).
Interventions
- Procedure Minimally invasive hernioplastia
laparoscopic or robotically assisted hernioplastia
Primary outcome measures
- Hernia recurrence rate [Time frame: 5 years (the time to recurrence will be defined by the moment of radiological confirmation)]
Secondary outcome measures (9)
- 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]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital Universitario Fundacion Jiménez Díaz — Madrid
Identifiers
NCT: NCT07544238 · PROMISER2026