Comparing preoperative preparation methods for large incisional (ventral) hernias
Comparative Evaluation of Different Preoperative Optimization Strategies in Patients With Large, Complex, and Giant Incisional Hernias
This study will test whether botulinum toxin A injections, progressive preoperative pneumoperitoneum, their combination, or no special preparation best help adults with large or complex incisional/ventral hernias have safer, more successful surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital Government |
| Locations | 1 site (Krasnodar, Krasnodarskiy Kray) |
| Trial ID | NCT07549113 on ClinicalTrials.gov |
What this trial studies
This is a prospective, comparative study that assigns patients with large or complex incisional (ventral) hernias to one of four preoperative strategies: botulinum toxin A injection, progressive pneumoperitoneum, the combination of both, or standard care without specific preparation. Treatment choice follows a differentiated algorithm based on clinical and anatomical characteristics of the hernia defect, and outcomes are tracked perioperatively and during follow-up. Primary and secondary outcomes include technical feasibility of repair, successful fascial closure, need for component separation, perioperative morbidity, length of stay, and recurrence. The study aims to identify which approach improves abdominal wall compliance and restoration of domain while minimizing complications.
Who should consider this trial
Good fit: Adults (18+) with large or complex ventral/incisional hernias scheduled for elective repair who can provide informed consent are the ideal candidates.
Not a fit: People requiring emergency hernia surgery, pregnant patients, those with contraindications to botulinum toxin A or pneumoperitoneum, or with severe uncontrolled comorbidities are unlikely to benefit from these preparatory techniques.
Why it matters
Potential benefit: If successful, the findings could help surgeons choose the preoperative method that increases the chance of tension-free closure and reduces complications and recurrence.
How similar studies have performed: Smaller series and observational studies have reported benefit from botulinum toxin A or progressive pneumoperitoneum individually and some combined-case reports are promising, but high-quality comparative data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Krasnodar, Krasnodarskiy Kray
- Ochapovsky Regional Clinical Hospital No.1 — Krasnodar, Krasnodarskiy Kray, Russia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.