Comparing preoperative preparation methods for large incisional (ventral) hernias
Official title: Comparative Evaluation of Different Preoperative Optimization Strategies in Patients With Large, Complex, and Giant Incisional Hernias
Run by State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital · NCT07549113 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital Government |
| Locations | 1 site (Krasnodar, Krasnodarskiy Kray) |
| Status | Recruiting |
| Started | April 1, 2024 |
| Main results expected | May 1, 2027 |
| Study ends | May 1, 2028 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT07549113 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with large or complex ventral/incisional hernias scheduled for elective repair who can provide informed consent are the ideal candidates.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Ochapovsky Regional Clinical Hospital No.1
Krasnodar, Krasnodarskiy Kray, Russia Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Integrated Mesh-Fascial Closure for Incisional Hernia Repair
This study tests whether incorporating a mesh into the fascial closure during incisional hernia repair helps reduce recurrences compared with standard closure, in adults who need mesh placement.
-
Epidural vs. opioid-sparing pain control after complex ventral hernia repair
This trial tests whether an epidural for pain relief after transversus abdominis release hernia repair works better than a non‑opioid, abdominal wall numbing injection approach.
-
Robotic Single-Port Ventral Hernia Repair
This study tests a robotic single-port ventral hernia repair using the da Vinci SP system to see if it’s safe and effective in adults.
-
Minimally invasive laparoscopic and robotic repair for non-inguinal abdominal wall hernias
This registry will follow adults having laparoscopic or robotic repair for abdominal wall hernias (not inguinal) for five years to see how well the operations work and what complications occur.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.