[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635163":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":36,"locations":51,"responsibleParty":72,"collaborators":36,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":36,"enrollmentInfo":84,"targetDuration":36,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":54,"whyStopped":36,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital","OTHER_GOV",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Botulinum Toxin A","EXPERIMENTAL","Preoperative chemical relaxation of the lateral abdominal wall muscles using botulinum toxin A before hernia repair.",[13],"Drug: Botulinum Toxin A (Botox )",{"label":15,"type":10,"description":16,"interventionNames":17},"Progressive Pneumoperitoneum","Preoperative progressive pneumoperitoneum used to increase abdominal cavity capacity before reconstruction.",[18],"Procedure: Progressive Preoperative Pneumoperitoneum",{"label":20,"type":10,"description":21,"interventionNames":22},"Combined Preparation","Combination of botulinum toxin A and progressive preoperative pneumoperitoneum before surgery",[23],"Procedure: Combined Preoperative Preparation",{"label":25,"type":26,"description":27,"interventionNames":28},"Standard Preparation","ACTIVE_COMPARATOR","Patients undergoing surgical repair without specific preoperative optimization techniques.",[29],"Other: Standard Preoperative Management",[31,37,42,46],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Botulinum Toxin A (Botox )","Preoperative injection of botulinum toxin A into the lateral abdominal wall musculature.",[9],null,{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":36},"PROCEDURE","Progressive Preoperative Pneumoperitoneum","Gradual insufflation of the peritoneal cavity before surgery.",[15],{"type":38,"name":43,"description":44,"armGroupLabels":45,"otherNames":36},"Combined Preoperative Preparation","Combination of botulinum toxin A and progressive pneumoperitoneum.",[20],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":36},"OTHER","Standard Preoperative Management","Routine preparation without specific optimization techniques.",[25],[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Ochapovsky Regional Clinical Hospital No.1","RECRUITING","Krasnodar","Krasnodarskiy Kray","350000","Russia","RU",{"type":61,"coordinates":62},"Point",[63,64],38.98178,45.04534,{"lat":64,"lon":63},[67],{"name":68,"role":69,"phone":70,"phoneExt":36,"email":71},"Aleksandr Petrovskii, MD, PhD","CONTACT","8(861) 285-05-40","aleksandr.petrovskii72@gmail.com",{"type":73,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100635163","comparative-evaluation-of-preoperative-preparation-methods-in-patients-with-large-incisional-hernias-100635163",false,"NCT07549113","Comparative Evaluation of Preoperative Preparation Methods in Patients With Large Incisional Hernias","Comparative Evaluation of Different Preoperative Optimization Strategies in Patients With Large, Complex, and Giant Incisional Hernias","AWR-PREP","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Patients with ventral incisional hernia requiring elective surgical repair\n* Large and\u002For complex hernia defects requiring preoperative preparation\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Age under 18 years\n* Emergency surgery\n* Pregnancy\n* Contraindications to botulinum toxin A injection or progressive pneumoperitoneum\n* Severe uncontrolled comorbidities precluding surgery\n* Inability or refusal to provide informed consent","ALL","18 Years",{"count":85,"type":86},120,"ESTIMATED","INTERVENTIONAL",[89],"NA","Patients with large, complex, or giant incisional hernias often require advanced preoperative optimization to facilitate safe abdominal wall reconstruction and reduce postoperative complications. Several strategies are currently used in clinical practice, including botulinum toxin A injection, progressive preoperative pneumoperitoneum, and their combination. However, the optimal differentiated approach based on hernia characteristics and abdominal wall tissue deficiency remains unclear.\n\nThis study aims to compare the effectiveness and safety of different preoperative preparation strategies in patients with large postoperative ventral hernias and loss of abdominal wall domain. Outcomes of patients receiving botulinum toxin A, progressive preoperative pneumoperitoneum, combined preparation, or no specific preparation will be analyzed.\n\nThe study will evaluate operative feasibility, ability to achieve fascial closure, postoperative complications, recurrence, and overall treatment outcomes.",[92,93],"Incisional Hernia Repair","Ventral Hernia Repair",[95,96,97,98,99,100,101,102,103],"Giant incisional hernia","Complex abdominal wall reconstruction","Botulinum toxin A","Progressive pneumoperitoneum","Preoperative optimization","Component separation","Hernia repair","Loss of domain","Ventral hernia surgery","2026-04-16",{"date":106,"type":107},"2026-04-23","ACTUAL",{"date":109,"type":107},"2024-04-01",{"date":111,"type":86},"2028-05-01",{"name":5,"class":6},1]