NCT07549113 Comparative Evaluation of Preoperative Preparation Methods in Patients With Large Incisional Hernias
| NCT ID | NCT07549113 |
| Status | Recruiting |
| Phase | — |
| Sponsor | State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital |
| Condition | Incisional Hernia Repair |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-04-01 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT07549113 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Incisional Hernia Repair. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07549113 currently recruiting?
Yes, NCT07549113 is actively recruiting participants. Visit ClinicalTrials.gov or contact State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital to inquire about joining.
Where is the NCT07549113 trial being conducted?
This trial is being conducted at Krasnodar, Russia.
Who is sponsoring the NCT07549113 clinical trial?
NCT07549113 is sponsored by State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital. The trial plans to enroll 120 participants.