Comparative Evaluation of Preoperative Preparation Methods in Patients With Large Incisional Hernias
Recruiting now · Not applicable
Conditions studied: Incisional Hernia Repair, Ventral Hernia Repair
In brief
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, ability to achieve fascial closure, postoperative complications, recurrence, and overall treatment outcomes.
Key facts
- Study ID
- NCT07549113
- Run by
- State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
- People needed
- 120
- Starts
- 2024-04-01
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2026-04-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Ochapovsky Regional Clinical Hospital No.1 — Krasnodar, Krasnodarskiy Kray, Russia (enrolling)
Full record on ClinicalTrials.gov
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