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

ConditionsIncisional Hernia RepairVentral Hernia Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorState Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age under 18 years

Emergency surgery

Pregnancy

Contraindications to botulinum toxin A injection or progressive pneumoperitoneum

Trial design

Design model

Parallel

Treatments tested in this trial

  • Botulinum Toxin A (Botox )

    Drug

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

  • Progressive Preoperative Pneumoperitoneum

    Procedure/Surgery

    Gradual insufflation of the peritoneal cavity before surgery.

  • Combined Preoperative Preparation

    Procedure/Surgery

    Combination of botulinum toxin A and progressive pneumoperitoneum.

  • Standard Preoperative Management

    Other intervention

    Routine preparation without specific optimization techniques.

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Botulinum Toxin AExperimental treatment 1 intervention
Group B: Progressive PneumoperitoneumExperimental treatment 1 intervention
Group C: Combined PreparationExperimental treatment 1 intervention
Group D: Standard PreparationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Successful Midline Fascial Closure Rate

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

Time frame
Intraoperative assessment

Secondary outcomes

1

Postoperative Complication Rate

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

Time frame
30 days after surgery
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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