Prospective Study of Minimally Invasive (Laparoscopic and Robotic) Hernia Repair (Incisional and Primary, Midline and Lateral, Not Inguinal)

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz400 enrolled

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).

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Ventral Hernia Midline Hernia Lumbar Incisional Hernia Repair

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

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

Time frame: 5 years (the time to recurrence will be defined by the moment of radiological confirmation)

Secondary Outcomes

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

Prospective Study of Minimally Invasive (Laparoscopic and Robotic) Hernia Repair (Incisional and Primary, Midline and Lateral, Not Inguinal)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts