Hernia Lumbar, Incisional Hernia Repair, Ventral Hernia Midline
Conditions
Brief 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).
Interventions
PROCEDUREMinimally invasive hernioplastia
laparoscopic or robotically assisted hernioplastia
Sponsors
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications Clavien Dindo | 90 days after surgery | Registration of postoperative complications according to the Clavien Dindo Definition |
| Surgical Site Occurrence (SSO) | 5 years | 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 | 30 days | 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 | 5 years | Percentage of the total of registered patients who perish |
| Hernia associated quality of life | 5 years | 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. |
| Postoperative pain | 24 and 48 hours after surgery (during the rest of the follow-up this value is included in the EuraHS QoL questionnaire) | 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) |
| Reintervention Rate | 5 years | Percentage of the total of registered patients with surgical reintervention due to complications of the performed surgery (hernia recurrence or others) |
| Risk Factors | Only at time of inclusion | 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 |
| Prehabilitation | at the time of registration | 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 |
Countries
Spain
Contacts
CONTACTMarius Kaeser, Doctors Degree
Outcome results
None listed