About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Indication for elective minimally invasive ventral hernia repair due to criteria of the participating surgeons
Disqualifiers
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 population
All adults referred to our department presenting an abdominal wall hernia with surgical indication
Trial design
Cohort
Prospective
Treatments tested in this trial
Minimally invasive hernioplastia
Procedure/Surgerylaparoscopic or robotically assisted hernioplastia
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Postoperative complications Clavien Dindo
Registration of postoperative complications according to the Clavien Dindo Definition
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)
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
Mortality
Percentage of the total of registered patients who perish
Sponsors and contacts
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