[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635163":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":35,"studyPopulation":20,"armGroups":36,"interventions":59,"overallOfficials":20,"centralContacts":20,"locations":79,"responsibleParty":100,"collaborators":20,"id":102,"slug":20,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":20,"enrollmentInfo":111,"targetDuration":20,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":82,"whyStopped":20,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Successful Midline Fascial Closure Rate","Proportion of patients in whom tension-free primary fascial closure is achieved during abdominal wall reconstruction.","Intraoperative assessment",[14,18,22,25],{"measure":15,"description":16,"timeFrame":17},"Postoperative Complication Rate","Overall postoperative morbidity including surgical and medical complications classified by Clavien-Dindo","30 days after surgery",{"measure":19,"description":20,"timeFrame":21},"Length of Hospital Stay",null,"From operation to discharge (up to 30 days)",{"measure":23,"description":20,"timeFrame":24},"Hernia Recurrence Rate","12 months after surgery",{"measure":26,"description":20,"timeFrame":12},"Need for Component Separation Technique",{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":20,"timePerspective":20,"maskingInfo":32},"NON_RANDOMIZED","PARALLEL","Participants are assigned to one of four parallel groups according to predefined clinical and anatomical criteria: botulinum toxin A, progressive preoperative pneumoperitoneum, combined preparation, or no specific preoperative preparation.","TREATMENT",{"masking":33,"maskingDescription":34,"whoMasked":20},"NONE","Open-label study due to the nature of the interventions","Large and giant incisional hernias remain a major challenge in abdominal wall surgery. In patients with loss of domain, reduced abdominal cavity volume, lateral muscle retraction, and soft tissue deficiency, standard hernia repair may be associated with high tension closure, respiratory compromise, abdominal compartment syndrome, wound complications, and recurrence.\n\nPreoperative optimization techniques such as chemical component relaxation with botulinum toxin A and progressive preoperative pneumoperitoneum have been increasingly used to improve abdominal wall compliance and restore abdominal domain. Combined use of these methods may provide additional benefit in selected patients.\n\nThe present prospective comparative study is designed to assess a differentiated treatment strategy in which the method of preoperative preparation is selected according to clinical and anatomical characteristics of the hernia defect.\n\nParticipants will be allocated to one of the following groups:\n\nBotulinum toxin A Progressive preoperative pneumoperitoneum Combined botulinum toxin A plus pneumoperitoneum No specific preoperative preparation\n\nPrimary and secondary outcomes may include technical feasibility of repair, need for component separation, successful fascial closure, perioperative morbidity, hospital stay, recurrence rate, and patient recovery.\n\nThe results of this study may help optimize patient selection and develop evidence-based algorithms for management of complex abdominal wall defects.",[37,43,48,53],{"label":38,"type":39,"description":40,"interventionNames":41},"Botulinum Toxin A","EXPERIMENTAL","Preoperative chemical relaxation of the lateral abdominal wall muscles using botulinum toxin A before hernia repair.",[42],"Drug: Botulinum Toxin A (Botox )",{"label":44,"type":39,"description":45,"interventionNames":46},"Progressive Pneumoperitoneum","Preoperative progressive pneumoperitoneum used to increase abdominal cavity capacity before reconstruction.",[47],"Procedure: Progressive Preoperative Pneumoperitoneum",{"label":49,"type":39,"description":50,"interventionNames":51},"Combined Preparation","Combination of botulinum toxin A and progressive preoperative pneumoperitoneum before surgery",[52],"Procedure: Combined Preoperative Preparation",{"label":54,"type":55,"description":56,"interventionNames":57},"Standard Preparation","ACTIVE_COMPARATOR","Patients undergoing surgical repair without specific preoperative optimization techniques.",[58],"Other: Standard Preoperative Management",[60,65,70,74],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":20},"DRUG","Botulinum Toxin A (Botox )","Preoperative injection of botulinum toxin A into the lateral abdominal wall musculature.",[38],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":20},"PROCEDURE","Progressive Preoperative Pneumoperitoneum","Gradual insufflation of the peritoneal cavity before surgery.",[44],{"type":66,"name":71,"description":72,"armGroupLabels":73,"otherNames":20},"Combined Preoperative Preparation","Combination of botulinum toxin A and progressive pneumoperitoneum.",[49],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":20},"OTHER","Standard Preoperative Management","Routine preparation without specific optimization techniques.",[54],[80],{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Ochapovsky Regional Clinical Hospital No.1","RECRUITING","Krasnodar","Krasnodarskiy Kray","350000","Russia","RU",{"type":89,"coordinates":90},"Point",[91,92],38.98178,45.04534,{"lat":92,"lon":91},[95],{"name":96,"role":97,"phone":98,"phoneExt":20,"email":99},"Aleksandr Petrovskii, MD, PhD","CONTACT","8(861) 285-05-40","aleksandr.petrovskii72@gmail.com",{"type":101,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","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":112,"type":113},120,"ESTIMATED","INTERVENTIONAL",[116],"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.",[119,120],"Incisional Hernia Repair","Ventral Hernia Repair",[122,123,124,125,126,127,128,129,130],"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":133,"type":134},"2026-04-23","ACTUAL",{"date":136,"type":134},"2024-04-01",{"date":138,"type":113},"2028-05-01",{"name":5,"class":6},1]