An observational study in Ventral Hernia Midline, Hernia Lumbar and Incisional Hernia Repair, sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Observational
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).
All adults referred to our department presenting an abdominal wall hernia with surgical indication
Exclusion Criteria:
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
Procedure: Minimally invasive hernioplastia
laparoscopic or robotically assisted hernioplastia
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
Time frame: 5 years (the time to recurrence will be defined by the moment of radiological confirmation)
Postoperative complications Clavien Dindo
Registration of postoperative complications according to the Clavien Dindo Definition
Time frame: 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)
Time frame: 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
Time frame: 30 days
Mortality
Percentage of the total of registered patients who perish
Time frame: 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.
Time frame: 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)
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
Percentage of the total of registered patients with surgical reintervention due to complications of the performed surgery (hernia recurrence or others)
Time frame: 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
Time frame: 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
Time frame: at the time of registration
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf
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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz