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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Minimally invasive hernioplastia

    Procedure/Surgery

    laparoscopic or robotically assisted hernioplastia

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: All adult patients with indication of elective minimally invasive abdominal wall hernia surgery1 intervention

Trial outcomes

Primary outcomes

1

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

1

Postoperative complications Clavien Dindo

Registration of postoperative complications according to the Clavien Dindo Definition

Time frame
90 days after surgery
2

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
3

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
4

Mortality

Percentage of the total of registered patients who perish

Time frame
5 years

Other outcomes

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