Incisional Hernia RepairAWR-PREPNCT07549113
Comparative Evaluation of Preoperative Preparation Methods in Patients With Large Incisional Hernias
A study testing Botulinum Toxin A (Botox ), Progressive Preoperative Pneumoperitoneum and Combined Preoperative Preparation in people with Incisional Hernia Repair and Ventral Hernia Repair, run by State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital at 1 site in Russia.
Trial summary
Patients with large, complex, or giant incisional hernias often require advanced preoperative optimization to facilitate safe abdominal wall reconstruction and reduce postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia Repair, Ventral Hernia Repair
- What is being tested?
- Botulinum Toxin A (Botox ), Progressive Preoperative Pneumoperitoneum and Combined Preoperative Preparation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2024to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Ochapovsky Regional Clinical Hospital No.1
Krasnodar, Krasnodarskiy Kray, 350000
Aleksandr Petrovskii, MD, PhD, 8(861) 285-05-40, aleksandr.petrovskii72@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Incisional Hernia Repair, Ventral Hernia Repair
- Being tested
- Botulinum Toxin A (Botox ), Progressive Preoperative Pneumoperitoneum, Combined Preoperative Preparation, Standard Preoperative Management
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin A (Botox )Drug
Preoperative injection of botulinum toxin A into the lateral abdominal wall musculature.
Progressive Preoperative PneumoperitoneumProcedure or surgery
Gradual insufflation of the peritoneal cavity before surgery.
Combined Preoperative PreparationProcedure or surgery
Combination of botulinum toxin A and progressive pneumoperitoneum.
Standard Preoperative ManagementOther
Routine preparation without specific optimization techniques.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin A | Experimental | Preoperative chemical relaxation of the lateral abdominal wall muscles using botulinum toxin A before hernia repair. Receives: Drug: Botulinum Toxin A (Botox ) |
| Progressive Pneumoperitoneum | Experimental | Preoperative progressive pneumoperitoneum used to increase abdominal cavity capacity before reconstruction. Receives: Procedure: Progressive Preoperative Pneumoperitoneum |
| Combined Preparation | Experimental | Combination of botulinum toxin A and progressive preoperative pneumoperitoneum before surgery Receives: Procedure: Combined Preoperative Preparation |
| Standard Preparation | Active comparator | Patients undergoing surgical repair without specific preoperative optimization techniques. Receives: Other: Standard Preoperative Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Midline Fascial Closure Rate
Proportion of patients in whom tension-free primary fascial closure is achieved during abdominal wall reconstruction.
Measured: Intraoperative assessment
Secondary outcomes (4)
Postoperative Complication Rate
Overall postoperative morbidity including surgical and medical complications classified by Clavien-Dindo
Measured: 30 days after surgery
Length of Hospital Stay
Measured: From operation to discharge (up to 30 days)
Hernia Recurrence Rate
Measured: 12 months after surgery
Need for Component Separation Technique
Measured: Intraoperative assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Apr 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional Hernia RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549113
- Sponsor's protocol ID
- AWR-PPP-BTA-2024
- Acronym
- AWR-PREP
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Different Preoperative Optimization Strategies in Patients With Large, Complex, and Giant Incisional Hernias
- ClinicalTrials.gov ID
- NCT07549113
- Acronym / sponsor ID
- AWR-PREP / AWR-PPP-BTA-2024
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical HospitalOther government
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin A | Experimental | Drug: Botulinum Toxin A (Botox )Preoperative chemical relaxation of the lateral abdominal wall muscles using botulinum toxin A before hernia repair. |
| Progressive Pneumoperitoneum | Experimental | Procedure: Progressive Preoperative PneumoperitoneumPreoperative progressive pneumoperitoneum used to increase abdominal cavity capacity before reconstruction. |
| Combined Preparation | Experimental | Procedure: Combined Preoperative PreparationCombination of botulinum toxin A and progressive preoperative pneumoperitoneum before surgery |
| Standard Preparation | Active comparator | Other: Standard Preoperative ManagementPatients undergoing surgical repair without specific preoperative optimization techniques. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Age under 18 years
- Emergency surgery
- Pregnancy
- Contraindications to botulinum toxin A injection or progressive pneumoperitoneum
- Severe uncontrolled comorbidities precluding surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin A (Botox )Preoperative injection of botulinum toxin A into the lateral abdominal wall musculature. | Drug | Botulinum Toxin A |
| Progressive Preoperative PneumoperitoneumGradual insufflation of the peritoneal cavity before surgery. | Procedure or surgery | Progressive Pneumoperitoneum |
| Combined Preoperative PreparationCombination of botulinum toxin A and progressive pneumoperitoneum. | Procedure or surgery | Combined Preparation |
| Standard Preoperative ManagementRoutine preparation without specific optimization techniques. | Other | Standard Preparation |
Primary outcome
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.
4 secondary outcomes
Postoperative Complication Rate
Time frame: 30 days after surgery
Length of Hospital Stay
Time frame: From operation to discharge (up to 30 days)
Hernia Recurrence Rate
Time frame: 12 months after surgery
Need for Component Separation Technique
Time frame: Intraoperative assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ochapovsky Regional Clinical Hospital No.1
Krasnodar, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin A (Botox ), Progressive Preoperative Pneumoperitoneum and Combined Preoperative Preparation in people with Incisional Hernia Repair and Ventral Hernia Repair, run by State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Midline Fascial Closure Rate (time frame: Intraoperative assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.