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

NCT07549113 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

  • Incisional Hernia Repair
  • Ventral Hernia Repair

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.

Sponsors & Collaborators

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

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2027-05-01
Completion
2028-05-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07549113 on ClinicalTrials.gov