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

NCT07544238 | Recruiting

• 1 other identifier: PROMISER2026
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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).

Conditions

Ventral Hernia Midline; Hernia Lumbar; Incisional Hernia Repair

Outcome Measures

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

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

Secondary Outcomes (9)

• Postoperative complications Clavien Dindo

  90 days after surgery

• Surgical Site Occurrence (SSO)

  5 years

• Perioperative bleeding

  30 days

• Mortality

  5 years

• Hernia associated quality of life

  5 years

Study Arms (1)

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

Interventions

Minimally invasive hernioplastia PROCEDURE

laparoscopic or robotically assisted hernioplastia

All adult patients with indication of elective minimally invasive abdominal wall hernia surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Indication for elective minimally invasive ventral hernia repair due to criteria of the participating surgeons

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Hospital Universitario Fundacion Jiménez Díaz

Madrid, Madrid, 28040, Spain

RECRUITING

Central Study Contacts

Marius Kaeser, Doctors Degree

CONTACT

0034 915 50 48 00; marius.kaser@quironsalud.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Staff, Surgeon in the department of General Surgery of the Hospital Universitario Fundación Jiménez Díaz

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: April 14, 2026
• Primary Completion (Estimated): April 14, 2036
• Study Completion (Estimated): April 14, 2036
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From the beginning until the end of the follow-up (from 14/04/2026 until the 14/04/2036)
• Access Criteria: Only the participating investigators of our hospital

Locations

ES (1)