NCT07544238|Recruiting
Prospective Study of Minimally Invasive (Laparoscopic and Robotic) Hernia Repair (Incisional and Primary, Midline and Lateral, Not Inguinal)
PROMISER
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PROMISER
Sponsor study identifier
observational
400
1 country
1
Study Start
April 14, 2026
Actual (reported)Primary Completion
April 14, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 14, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 14, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 14, 2026
Actual (reported)April 15, 2026
Actual (reported)April 22, 2026
Actual (reported)April 14, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 14, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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)
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
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
laparoscopic or robotically assisted hernioplastia
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All adults referred to our department presenting an abdominal wall hernia with surgical indication
Hospital Universitario Fundacion Jiménez Díaz
Madrid, Madrid, 28040, Spain
First Submitted
April 15, 2026
First Posted
April 22, 2026
Study Start
April 14, 2026
Actual (reported)Primary Completion
April 14, 2036
Comparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 14, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 27, 2026
Record last verified: 2026-04
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.
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Source: ClinicalTrials.gov.
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