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Comparative Evaluation of Preoperative Preparation Methods in Patients With Large Incisional Hernias

RecruitingNAAges 18 Years - anyAllState Budget Public Health Institution Scientific…
NCT07549113 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. This 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. The study will evaluate operative feasibility, abilit

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged 18 years or older * Patients with ventral incisional hernia requiring elective surgical repair * Large and/or complex hernia defects requiring preoperative preparation * Ability to provide informed consent Exclusion Criteria: * Age under 18 years * Emergency surgery * Pregnancy * Contraindications to botulinum toxin A injection or progressive pneumoperitoneum * Severe uncontrolled comorbidities precluding surgery * Inability or refusal to provide informed consent
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What it tests

  • Botulinum Toxin A (Botox )
  • Progressive Preoperative Pneumoperitoneum
  • Combined Preoperative Preparation
  • Standard Preoperative Management
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Where

1 site
Ochapovsky Regional Clinical Hospital No.1
Krasnodar, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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