RecruitingNot ApplicableNCT07549113

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

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


Sponsor

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

Enrollment

120 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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

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Interventions

DRUGBotulinum Toxin A (Botox )

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.


Locations(1)

Ochapovsky Regional Clinical Hospital No.1

Krasnodar, Krasnodarskiy Kray, Russia

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NCT07549113


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