Comparative Evaluation of Preoperative Preparation Methods in Patients With Large Incisional Hernias (AWR-PREP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ventral Hernia Repair; Incisional Hernia Repair
• Intervention / Treatment: Drug: Botulinum Toxin A (Botox ); Procedure: Progressive Preoperative Pneumoperitoneum; Procedure: Combined Preoperative Preparation; Other: Standard Preoperative Management

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russia
  • Krasnodarskiy Kray
    • Krasnodar, Krasnodarskiy Kray, Russia, 350000
      • Recruiting
      • Ochapovsky Regional Clinical Hospital No.1
      • Contact: Aleksandr Petrovskii, MD, PhD; Phone Number: 8(861) 285-05-40; Email: aleksandr.petrovskii72@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botulinum Toxin A; Preoperative chemical relaxation of the lateral abdominal wall muscles using botulinum toxin A before hernia repair.	Drug: Botulinum Toxin A (Botox ); Preoperative injection of botulinum toxin A into the lateral abdominal wall musculature.
Experimental: Progressive Pneumoperitoneum; Preoperative progressive pneumoperitoneum used to increase abdominal cavity capacity before reconstruction.	Procedure: Progressive Preoperative Pneumoperitoneum; Gradual insufflation of the peritoneal cavity before surgery.
Experimental: Combined Preparation; Combination of botulinum toxin A and progressive preoperative pneumoperitoneum before surgery	Procedure: Combined Preoperative Preparation; Combination of botulinum toxin A and progressive pneumoperitoneum.
Active Comparator: Standard Preparation; Patients undergoing surgical repair without specific preoperative optimization techniques.	Other: Standard Preoperative Management; Routine preparation without specific optimization techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Midline Fascial Closure Rate	Proportion of patients in whom tension-free primary fascial closure is achieved during abdominal wall reconstruction.	Intraoperative assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Complication Rate	Overall postoperative morbidity including surgical and medical complications classified by Clavien-Dindo	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Botulinum toxin A; Hernia repair; Component separation; Giant incisional hernia; Complex abdominal wall reconstruction; Progressive pneumoperitoneum; Preoperative optimization; Loss of domain; Ventral hernia surgery
• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Hydrolases; Enzymes; Enzymes and Coenzymes; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Metalloproteases; Bacterial Proteins; Bacterial Toxins; Toxins, Biological; Botulinum Toxins, Type A
• Other Study ID Numbers: AWR-PPP-BTA-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No