Comparative Evaluation of Preoperative Preparation Methods in Patients With Large Incisional Hernias
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Botulinum Toxin A (Botox ), Progressive Preoperative Pneumoperitoneum, Combined Preoperative Preparation, Standard Preoperative Management.
- Who it may be relevant to
- Registry conditions: Incisional Hernia Repair, Ventral Hernia Repair. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Evaluation of Different Preoperative Optimization Strategies in Patients With Large, Complex, and Giant Incisional Hernias
Overview
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
- Drug Botulinum Toxin A (Botox )
Preoperative injection of botulinum toxin A into the lateral abdominal wall musculature. - Procedure Progressive Preoperative Pneumoperitoneum
Gradual insufflation of the peritoneal cavity before surgery. - Procedure Combined Preoperative Preparation
Combination of botulinum toxin A and progressive pneumoperitoneum. - Other Standard Preoperative Management
Routine preparation without specific optimization techniques.
Primary outcome measures
- Successful Midline Fascial Closure Rate [Time frame: Intraoperative assessment]
Secondary outcome measures (4)
- Postoperative Complication Rate [Time frame: 30 days after surgery]
- Length of Hospital Stay [Time frame: From operation to discharge (up to 30 days)]
- Hernia Recurrence Rate [Time frame: 12 months after surgery]
- Need for Component Separation Technique [Time frame: Intraoperative assessment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- Ochapovsky Regional Clinical Hospital No.1 — Krasnodar
Identifiers
NCT: NCT07549113 · AWR-PPP-BTA-2024