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Recruiting Not applicable NCT07549113

Comparative Evaluation of Preoperative Preparation Methods in Patients With Large Incisional Hernias

No applicable phase (e.g. observational)
Conditions: Incisional Hernia Repair Ventral Hernia Repair

Sponsor: State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital

trial.available_in: БГ
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.
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.
Who can participate
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
Interventions
Botulinum Toxin A (Botox )
DRUG
Progressive Preoperative Pneumoperitoneum
PROCEDURE
Combined Preoperative Preparation
PROCEDURE
Standard Preoperative Management
OTHER
Locations 1
Russia (1)
Ochapovsky Regional Clinical Hospital No.1
Krasnodar , Krasnodarskiy Kray
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.04.2024
Completion date
01.05.2028
Registry ID
NCT07549113
Source
clinicaltrials.gov
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