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

Prospective Study of Minimally Invasive Hernia Repair

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 Overview

• Status: Recruiting
• Conditions: Hernia Lumbar; Ventral Hernia Midline; Incisional Hernia Repair
• Intervention / Treatment: Procedure: Minimally invasive hernioplastia

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Marius Kaeser, Doctors Degree; Phone Number: 4331 0034 915 50 48 00; Email: marius.kaser@quironsalud.es

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28040
      • Recruiting
      • Hospital Universitario Fundacion Jimenez Diaz
      • Contact: Marius Kaeser, Doctors Degree; Phone Number: +4331 0034 915 50 48 00; Email: marius.kaser@quironsalud.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All adults referred to our department presenting an abdominal wall hernia with surgical indication

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All adult patients with indication of elective minimally invasive abdominal wall hernia surgery; The patients will be intervened by laparoscopic or robotically assisted hernioplastia of midline or lumbar hernias, either primary or secondary in nature. Inguinal hernias will only be included if they exist apart from the primarily targeted midline or lumbar abdominal wall hernia	Procedure: Minimally invasive hernioplastia; laparoscopic or robotically assisted hernioplastia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 years (the time to recurrence will be defined by the moment of radiological confirmation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications Clavien Dindo	Registration of postoperative complications according to the Clavien Dindo Definition	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)	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	30 days
Mortality	Percentage of the total of registered patients who perish	5 years
Reintervention Rate	Percentage of the total of registered patients with surgical reintervention due to complications of the performed surgery (hernia recurrence or others)	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	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	at the time of registration
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.	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)	24 and 48 hours after surgery (during the rest of the follow-up this value is included in the EuraHS QoL questionnaire)

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2026
• Primary Completion (Estimated): April 14, 2036
• Study Completion (Estimated): April 14, 2036

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PROMISER2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All the raw data registered and relevant for the described primary and secondary outcomes, but NOT the personal details necessary to identify the person (birth date, name, medical record number). In essence: only the pseudonymized data is provided.
• IPD Sharing Time Frame: From the beginning until the end of the follow-up (from 14/04/2026 until the 14/04/2036)
• IPD Sharing Access Criteria: Only the participating investigators of our hospital
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No