[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532994":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":61,"collaborators":24,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":24,"enrollmentInfo":75,"targetDuration":24,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Polyvinylidene fluoride mesh","EXPERIMENTAL","In all patients, surgery will be performed according to their individual pathology. Once midline laparotomy closure is initiated, randomization will be conducted, and patients will be assigned to one of the two groups.\n\nPVDF Group (Polyvinylidene Fluoride Mesh): Midline laparotomy closure using the \"small bites\" technique associated with a prophylactic suprafascial polyvinylidene fluoride mesh",[13],"Combination Product: Polyvinylidene fluoride mesh",{"label":15,"type":10,"description":16,"interventionNames":17},"Prophylactic polypropylene mesh","In all patients, surgery will be performed according to their individual pathology. Once midline laparotomy closure is initiated, randomization will be conducted, and patients will be assigned to one of the two groups.\n\nPP Group (Polypropylene Mesh): Midline laparotomy closure using the \"small bites\" technique associated with a prophylactic suprafascial polypropylene mesh.",[18],"Combination Product: Prophylactic polypropylene mesh",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"COMBINATION_PRODUCT","Midline laparotomy closure using the \"small bites\" technique associated with a prophylactic suprafascial polyvinylidene fluoride mesh.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Midline laparotomy closure using the \"small bites\" technique associated with a prophylactic suprafascial polypropylene mesh.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Frank Fernández, Dr.","CONTACT","972 94 02 60","cirurgia.girona.ics@gencat.cat",[35],{"facility":36,"status":37,"city":38,"state":24,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Colorectal Surgery Section, Department of General and Digestive Surgery, University Hospital of Girona,","RECRUITING","Girona","17001","Spain","ES",{"type":43,"coordinates":44},"Point",[45,46],2.82493,41.98311,{"lat":46,"lon":45},[49,52,55,57,59],{"name":50,"role":31,"phone":32,"phoneExt":24,"email":51},"Frank Fernández","frankafernandez.girona.ics@gencat.cat",{"name":53,"role":54,"phone":24,"phoneExt":24,"email":24},"Pere Planellas, Dr.","SUB_INVESTIGATOR",{"name":56,"role":54,"phone":24,"phoneExt":24,"email":24},"Ramon Farrés, Dr.",{"name":58,"role":54,"phone":24,"phoneExt":24,"email":24},"Jorge García-Adámez, Dr.",{"name":60,"role":54,"phone":24,"phoneExt":24,"email":24},"Lidia Cornejo, MsC",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Fernandez Zamora","Principal Investigator","100532994","comparing-pp-and-pvdf-meshes-in-midline-laparotomy-closure-for-high-risk-colorectal-surgery-impact-on-incisional-hernia-and-surgical-wound-infection-100532994",false,"NCT06220045","Comparing PP and PVDF Meshes in Midline Laparotomy Closure for High-risk Colorectal Surgery. Impact on Incisional Hernia and Surgical Wound Infection.","Comparison Between the Use of a Polypropylene (PP) Prophylactic Mesh and a Polyvinylidene Fluoride (PVDF) Mesh in the Closure of Midline Laparotomy in Emergency Colorectal Surgery for High-risk Patients of Incisional Hernia. Impact on Surgical Wound Infection.","PROFIMESH","Inclusion Criteria:\n\n* Patients diagnosed with colorectal pathology requiring urgent surgical treatment via midline laparotomy.\n* Patients undergoing urgent laparoscopic surgery but requiring conversion to midline laparotomy.\n* Need for urgent surgical treatment involving the colon and\u002For rectum, even in the presence of other abdominal pathologies.\n* Age over 18 years.\n* Signed informed consent (IC) from both the patient and the investigator\n* Severe chronic obstructive pulmonary disease (COPD) according to the GOLD classification or decompensated COPD.\n* BMI ≥ 35 kg\u002Fm2.\n* Re-laparotomies.\n\nExclusion Criteria:\n\n* Patients with psychiatric illnesses, addictions, or any disorder hindering the understanding of the Informed Consent.\n* Inability to read or comprehend any of the languages in the Informed Consent (Catalan, Spanish).","ALL","18 Years",{"count":76,"type":77},60,"ESTIMATED","INTERVENTIONAL",[80],"NA","In the latest guidelines for abdominal wall closure in emergency surgery published in the World Journal of Emergency Surgery (WJES) in 2023, no specific recommendations are made in this regard.\n\nCurrent literature does not provide any articles comparing these two types of mesh materials (PP vs PVDF) in emergency colorectal surgery. It is necessary to conduct a study comparing these two types of mesh materials, specifically in high-risk patients for incisional hernia and emergency colorectal surgery. This study aims to contribute to generating evidence regarding differences in wound infection incidence and potential subsequent complications, such as chronic pain.\n\nIt is essential to conduct a study comparing different methods of laparotomy closure, specifically in emergency colorectal surgery, to contribute valuable evidence regarding the incidence of incisional hernia and potential subsequent complications.",[83,84,85],"Colorectal Cancer","Wound Infection","Hernia Incisional",[87,84,85,88,89,90],"Colorectal cancer","Mesh","Polypropylene","PVDF","2024-10-06",{"date":93,"type":94},"2024-10-08","ACTUAL",{"date":96,"type":94},"2024-02-01",{"date":98,"type":77},"2025-01-15",{"name":5,"class":6},1]