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

NCT07549113 | Recruiting

• 1 other identifier: AWR-PPP-BTA-2024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Giant incisional hernia; Complex abdominal wall reconstruction; Botulinum toxin A; Progressive pneumoperitoneum; Preoperative optimization; Component separation; Hernia repair; Loss of domain; Ventral hernia surgery

Outcome Measures

Primary Outcomes (1)

• Successful Midline Fascial Closure Rate

  Proportion of patients in whom tension-free primary fascial closure is achieved during abdominal wall reconstruction.

  Intraoperative assessment

Secondary Outcomes (4)

• Postoperative Complication Rate

  30 days after surgery

• Length of Hospital Stay

  From operation to discharge (up to 30 days)

• Hernia Recurrence Rate

  12 months after surgery

• Need for Component Separation Technique

  Intraoperative assessment

Study Arms (4)

Botulinum Toxin A

EXPERIMENTAL

Preoperative chemical relaxation of the lateral abdominal wall muscles using botulinum toxin A before hernia repair.

Drug: Botulinum Toxin A (Botox )

Progressive Pneumoperitoneum

EXPERIMENTAL

Preoperative progressive pneumoperitoneum used to increase abdominal cavity capacity before reconstruction.

Procedure: Progressive Preoperative Pneumoperitoneum

Combined Preparation

EXPERIMENTAL

Combination of botulinum toxin A and progressive preoperative pneumoperitoneum before surgery

Procedure: Combined Preoperative Preparation

Standard Preparation

ACTIVE COMPARATOR

Patients undergoing surgical repair without specific preoperative optimization techniques.

Other: Standard Preoperative Management

Interventions

Botulinum Toxin A (Botox ) DRUG

Preoperative injection of botulinum toxin A into the lateral abdominal wall musculature.

Botulinum Toxin A

Progressive Preoperative Pneumoperitoneum PROCEDURE

Gradual insufflation of the peritoneal cavity before surgery.

Progressive Pneumoperitoneum

Combined Preoperative Preparation PROCEDURE

Combination of botulinum toxin A and progressive pneumoperitoneum.

Combined Preparation

Standard Preoperative Management OTHER

Routine preparation without specific optimization techniques.

Standard Preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Ochapovsky Regional Clinical Hospital No.1

Krasnodar, Krasnodarskiy Kray, 350000, Russia

RECRUITING

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open-label study due to the nature of the interventions
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of four parallel groups according to predefined clinical and anatomical criteria: botulinum toxin A, progressive preoperative pneumoperitoneum, combined preparation, or no specific preoperative preparation.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 23, 2026
• Study Start: April 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

RU (1)