[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634788":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":47,"studyPopulation":51,"armGroups":52,"interventions":58,"overallOfficials":47,"centralContacts":64,"locations":71,"responsibleParty":88,"collaborators":47,"id":92,"slug":47,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":47,"enrollmentInfo":101,"targetDuration":104,"studyType":105,"phases":47,"briefSummary":106,"conditions":107,"keywords":47,"overallStatus":74,"whyStopped":47,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"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\u002For 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)",[14,18,22,26,29,32,36,39,43],{"measure":15,"description":16,"timeFrame":17},"Postoperative complications Clavien Dindo","Registration of postoperative complications according to the Clavien Dindo Definition","90 days after surgery",{"measure":19,"description":20,"timeFrame":21},"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",{"measure":23,"description":24,"timeFrame":25},"Perioperative bleeding","Any drop in serum hemoglobin levels \\> 2 g\u002Fdl within 24 hours or \\> 3 g\u002Fdl compared to preoperative values or hemodynamically relevant bleeding or necessity for blood transfusion or surgical reintervention because of bleeding","30 days",{"measure":27,"description":28,"timeFrame":21},"Mortality","Percentage of the total of registered patients who perish",{"measure":30,"description":31,"timeFrame":21},"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.",{"measure":33,"description":34,"timeFrame":35},"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)",{"measure":37,"description":38,"timeFrame":21},"Reintervention Rate","Percentage of the total of registered patients with surgical reintervention due to complications of the performed surgery (hernia recurrence or others)",{"measure":40,"description":41,"timeFrame":42},"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",{"measure":44,"description":45,"timeFrame":46},"Prehabilitation","Description of the percentage of patients treated with either Botox injection into the abdominal wall within 8 weeks before surgery and \u002F or pulmonary prehabilitation and \u002F or included in a weight loss program before surgery and \u002F or have canceled an existing smoking habit before surgery","at the time of registration",null,{"allocation":47,"interventionModel":47,"interventionModelDescription":47,"primaryPurpose":47,"observationalModel":49,"timePerspective":50,"maskingInfo":47},"COHORT","PROSPECTIVE","All adults referred to our department presenting an abdominal wall hernia with surgical indication",[53],{"label":54,"type":47,"description":55,"interventionNames":56},"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",[57],"Procedure: Minimally invasive hernioplastia",[59],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":47},"PROCEDURE","Minimally invasive hernioplastia","laparoscopic or robotically assisted hernioplastia",[54],[65],{"name":66,"role":67,"phone":68,"phoneExt":69,"email":70},"Marius Kaeser, Doctors Degree","CONTACT","0034 915 50 48 00","4331","marius.kaser@quironsalud.es",[72],{"facility":73,"status":74,"city":75,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Hospital Universitario Fundacion Jiménez Díaz","RECRUITING","Madrid","28040","Spain","ES",{"type":80,"coordinates":81},"Point",[82,83],-3.70256,40.4165,{"lat":83,"lon":82},[86],{"name":66,"role":67,"phone":68,"phoneExt":87,"email":70},"+4331",{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"PRINCIPAL_INVESTIGATOR","Marius Kaeser","Surgical Staff, Surgeon in the department of General Surgery of the Hospital Universitario Fundación Jiménez Díaz","100634788",false,"NCT07544238","Prospective Study of Minimally Invasive (Laparoscopic and Robotic) Hernia Repair (Incisional and Primary, Midline and Lateral, Not Inguinal)","Prospective Study of Minimally Invasive Hernia Repair","PROMISER","Inclusion Criteria:\n\n* Indication for elective minimally invasive ventral hernia repair due to criteria of the participating surgeons\n\nExclusion Criteria:\n\n* Patient rejects participation or giving written informed consent\n* Positive pregnancy test (Beta HCG in serum)\n* 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)","ALL","18 Years",{"count":102,"type":103},400,"ESTIMATED","5 Years","OBSERVATIONAL","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.\n\nThe 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).",[108,109,110],"Ventral Hernia Midline","Hernia Lumbar","Incisional Hernia Repair","2026-04-22",{"date":113,"type":114},"2026-04-27","ACTUAL",{"date":116,"type":114},"2026-04-14",{"date":118,"type":103},"2036-04-14",{"name":5,"class":6},1]