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NCT Number: NCT07549113

Comparative Evaluation of Preoperative Preparation Methods in Patients With Large 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.

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Key information

Conditions

Incisional Hernia Repair Ventral Hernia Repair

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ochapovsky Regional Clinical Hospital No.1

Krasnodar, Krasnodarskiy Kray, 350000, Russia

Location status: Recruiting

Location contact

Aleksandr Petrovskii, MD, PhD

CONTACT

[email protected]

8(861) 285-05-40

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin A (Botox )

Drug

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

Progressive Preoperative Pneumoperitoneum

Procedure

Gradual insufflation of the peritoneal cavity before surgery.

Combined Preoperative Preparation

Procedure

Combination of botulinum toxin A and progressive pneumoperitoneum.

Standard Preoperative Management

Other

Routine preparation without specific optimization techniques.

Primary outcomes

  1. Successful Midline Fascial Closure Rate

    Time frame: Intraoperative assessment

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

Secondary outcomes

  1. Postoperative Complication Rate

    Time frame: 30 days after surgery

    Overall postoperative morbidity including surgical and medical complications classified by Clavien-Dindo

  2. Length of Hospital Stay

    Time frame: From operation to discharge (up to 30 days)

  3. Hernia Recurrence Rate

    Time frame: 12 months after surgery

  4. Need for Component Separation Technique

    Time frame: Intraoperative assessment

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Acronym: AWR-PREP

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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