Minimally invasive hernioplastia: laparoscopic or robotically assisted hernioplastia
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Hernia recurrence rate — 5 years (the time to recurrence will be defined by the moment of radiological confirmation) 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
Trial sites (1)
Facility
City
Region
Status
Hospital Universitario Fundacion Jiménez Díaz
Madrid
Madrid
Recruiting
More Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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