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Comparative Evaluation of Different Preoperative Optimization Strategies in Patients With Large, Complex, and Giant Incisional Hernias

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Ochapovsky Regional Clinical Hospital No.1
RECRUITING
Krasnodar
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2028-05-01
Participants
Target number of participants: 120
Treatments
Experimental: Botulinum Toxin A
Preoperative chemical relaxation of the lateral abdominal wall muscles using botulinum toxin A before hernia repair.
Experimental: Progressive Pneumoperitoneum
Preoperative progressive pneumoperitoneum used to increase abdominal cavity capacity before reconstruction.
Experimental: Combined Preparation
Combination of botulinum toxin A and progressive preoperative pneumoperitoneum before surgery
Active_comparator: Standard Preparation
Patients undergoing surgical repair without specific preoperative optimization techniques.
Related Therapeutic Areas
Sponsors
Leads: State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital

This content was sourced from clinicaltrials.gov