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NCT Number: NCT07544238

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

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).

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Key information

Conditions

Ventral Hernia Midline Hernia Lumbar Incisional Hernia Repair

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Fundacion Jiménez Díaz

Madrid, 28040, Spain

Location status: Recruiting

Location contact

Marius Kaeser, Doctors Degree

CONTACT

[email protected]

0034 915 50 48 00 ext. +4331

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Minimally invasive hernioplastia

Procedure

laparoscopic or robotically assisted hernioplastia

Primary outcomes

  1. Hernia recurrence rate

    Time frame: 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 outcomes

  1. Postoperative complications Clavien Dindo

    Time frame: 90 days after surgery

    Registration of postoperative complications according to the Clavien Dindo Definition

  2. Surgical Site Occurrence (SSO)

    Time frame: 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)

  3. Perioperative bleeding

    Time frame: 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

  4. Mortality

    Time frame: 5 years

    Percentage of the total of registered patients who perish

  5. Hernia associated quality of life

    Time frame: 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.

  6. Postoperative pain

    Time frame: 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)

  7. Reintervention Rate

    Time frame: 5 years

    Percentage of the total of registered patients with surgical reintervention due to complications of the performed surgery (hernia recurrence or others)

  8. Risk Factors

    Time frame: 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

  9. Prehabilitation

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Marius Kaeser, Doctors Degree

CONTACT

[email protected]

0034 915 50 48 00 ext. 4331

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Other

Registry information

Official study title

Prospective Study of Minimally Invasive Hernia Repair

Acronym: PROMISER

Important dates

Study start
2026
Primary completion
2036
Study completion
2036
First posted
Apr 22, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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