Incisional Hernia Repair, Ventral Hernia Repair
Conditions
Keywords
Giant incisional hernia, Complex abdominal wall reconstruction, Botulinum toxin A, Progressive pneumoperitoneum, Preoperative optimization, Component separation, Hernia repair, Loss of domain, Ventral hernia surgery
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.
Detailed description
Large and giant incisional hernias remain a major challenge in abdominal wall surgery. In patients with loss of domain, reduced abdominal cavity volume, lateral muscle retraction, and soft tissue deficiency, standard hernia repair may be associated with high tension closure, respiratory compromise, abdominal compartment syndrome, wound complications, and recurrence. Preoperative optimization techniques such as chemical component relaxation with botulinum toxin A and progressive preoperative pneumoperitoneum have been increasingly used to improve abdominal wall compliance and restore abdominal domain. Combined use of these methods may provide additional benefit in selected patients. The present prospective comparative study is designed to assess a differentiated treatment strategy in which the method of preoperative preparation is selected according to clinical and anatomical characteristics of the hernia defect. Participants will be allocated to one of the following groups: Botulinum toxin A Progressive preoperative pneumoperitoneum Combined botulinum toxin A plus pneumoperitoneum No specific preoperative preparation Primary and secondary outcomes may include technical feasibility of repair, need for component separation, successful fascial closure, perioperative morbidity, hospital stay, recurrence rate, and patient recovery. The results of this study may help optimize patient selection and develop evidence-based algorithms for management of complex abdominal wall defects.
Interventions
Preoperative injection of botulinum toxin A into the lateral abdominal wall musculature.
PROCEDUREProgressive Preoperative Pneumoperitoneum
Gradual insufflation of the peritoneal cavity before surgery.
PROCEDURECombined Preoperative Preparation
Combination of botulinum toxin A and progressive pneumoperitoneum.
OTHERStandard Preoperative Management
Routine preparation without specific optimization techniques.
Sponsors
State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label study due to the nature of the interventions
Intervention model description
Participants are assigned to one of four parallel groups according to predefined clinical and anatomical criteria: botulinum toxin A, progressive preoperative pneumoperitoneum, combined preparation, or no specific preoperative preparation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Midline Fascial Closure Rate | Intraoperative assessment | Proportion of patients in whom tension-free primary fascial closure is achieved during abdominal wall reconstruction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Complication Rate | 30 days after surgery | Overall postoperative morbidity including surgical and medical complications classified by Clavien-Dindo |
| Length of Hospital Stay | From operation to discharge (up to 30 days) | — |
| Hernia Recurrence Rate | 12 months after surgery | — |
| Need for Component Separation Technique | Intraoperative assessment | — |
Countries
Russia
Outcome results
None listed