HerniaPhase 2ProbheNCT07628205
Preoperative Botulinum Toxin A to Facilitate Midline Closure in Large Chronic Ventral Hernias
A Phase 2 study testing Posterior Component Separation (PCS) with TAR and Rives-Stoppa in people with Hernia, run by Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano at 1 site in Italy.
Trial summary
In patients with large hernias, chronic retraction of the lateral abdominal wall muscles, and visceral contents that are irreducible within the hernia sac, closure of the midline can be difficult or even impossible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia
- What is being tested?
- Posterior Component Separation (PCS) with TAR and Rives-Stoppa
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 17 Feb 2026to 17 Feb 2029
- Phase
- Phase 2
- 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
- Participant is willing and able to give informed consent for participation in the trial
- Compliance to follow-up
- Male and female
- Written informed consent to preoperative BTA injection and/or surgery
- Age 18 years old
- Primary ventral hernia
Show all 10Show fewer
- Incisional ventral hernia
- RDR < 2
- Defect width 10 cm
- Loss of domain (LoD) 20%
Who cannot join
- Medical or psychiatric conditions that compromises the patient's ability to give informed
- consent or comply with the study protocol
- Personal reasons
- Age < 18 years old
- RDR ≥ 2
- Defect width < 10 cm
Show all 11Show fewer
- LoD < 20%
- Pregnancy and breastfeeding
- Allergy/Intolerance to BTA
- Neuromuscular disorders and diseases
- Refuse to give informed consent to preoperative BTA injection and/or surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prehabilitation With Botulinum Toxin A in Complex Hernia: an Italian Prospective Study on Predictive Scores of Myofascial Release.
In patients with large hernias, chronic retraction of the lateral abdominal wall muscles, and visceral contents that are irreducible within the hernia sac, closure of the midline can be difficult or even impossible. Component separation techniques (CST), in combination with transversus abdominis release (TAR), increase the flexibility of the abdominal wall and facilitate fascial medialization. However, these techniques alter the anatomy of the abdominal wall and are associated with higher risks of wound complications, abdominal wall disruption, and abdominal compartment syndrome (ACS).
Recently, the preoperative injection of Botulinum Toxin A (BTA) has been proposed as an effective form of chemical component separation of the muscles, or more precisely, chemical relaxation. It has been hypothesized that preoperative chemical paralysis of the lateral abdominal wall muscles through BTA increases abdominal wall compliance and facilitates fascial medialization, thereby reducing the need to resort to CST.
However, the current literature still lacks studies evaluating the impact of BTA on predictive scores for myofascial release and the correlation with intraoperative strategies.
- Conditions
- Hernia
- Being tested
- Posterior Component Separation (PCS) with TAR, Rives-Stoppa
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Component Separation (PCS) with TARProcedure or surgery
Posterior Component Separation (PCS) with Transversus Abdominis Release (TAR) is an intraoperative surgical technique performed by the surgeon when a standard retromuscular repair, such as the Rives-Stoppa technique, does not allow for tension-free midline closure. In such cases, additional myofascial release is required, and PCS with TAR is subsequently performed to achieve adequate medial advancement of the abdominal wall components and enable secure, tension-free closure of the midline defect.
Rives-StoppaProcedure or surgery
Rives-Stoppa repair is a retromuscular abdominal wall reconstruction technique used when primary fascial closure can be achieved without the need for additional myofascial release. It represents a less invasive approach compared to component separation techniques, such as Posterior Component Separation with Transversus Abdominis Release (PCS with TAR), and is performed in cases where tension-free midline closure is feasible using a standard retromuscular plane dissection.
| Study group | Role | What they receive |
|---|---|---|
| Posterior Component Separation (PCS) with TAR after BTA injection. | Experimental | Not described Receives: Procedure: Posterior Component Separation (PCS) with TAR |
| Rives-Stoppa surgery after BTA injection | Experimental | Not described Receives: Procedure: Rives-Stoppa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Preoperative Indices Following Botulinum Toxin A Injection
Changes in preoperative radiological indices following Botulinum Toxin A (BTA) injection will be assessed using abdominal computed tomography (CT) scans. The Rectus-to-Defect Ratio (RDR) will be calculated on pre- and post-injection CT imaging; each 0.5-point increase in RDR is associated with an approximate 20% linear reduction in the need for anterior myofascial release (AMR). The Component Separation Index (CSI) will be determined on axial CT images using the aorta as a fixed reference point and the medial borders of the rectus abdominis muscles. Abdominal cavity volume will be estimated using the ellipsoid volume formula based on craniocaudal, transverse, and anteroposterior diameters measured on CT imaging. Pre- and post-BTA values will be compared to evaluate improvement in abdominal wall compliance and anatomical reconstruction parameters.
Measured: Enrollment, 4 weeks after BTA injection, and 12 months after surgery
Secondary outcomes (1)
Association Between Changes in Preoperative Indices After Botulinum Toxin A Injection and Surgical Strategy Selection.
Two surgical strategies will be considered based on abdominal wall reconstruction requirements: (A) Posterior Component Separation (PCS) with Transversus Abdominis Release (TAR), and (B) Rives-Stoppa repair, performed when no myofascial release is required. For PCS with TAR procedures, the Posterior Bridging Ratio (PBR) and Anterior Bridging Ratio (ABR) will be assessed as the proportion of the peritoneal sac used as a bridge to achieve tension-free closure of the posterior and anterior fascial layers, respectively. The extent of ABR and PBR will be analyzed in relation to the preoperative effect of Botulinum Toxin A (BTA) injection. In particular, higher percentages (>50%) of PBR and ABR will be considered indicative of poor BTA efficacy, intermediate values (25-50%) of partial efficacy, and low values (0-25%) of good to very good BTA efficacy. The relationship between changes in preoperative indices after BTA administration and the selected surgical approach will be evaluated.
Measured: until the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start17 Feb 2026
- Primary completion1 Jan 2029 (estimated)
- Study completion17 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628205
- Sponsor's protocol ID
- 57-2024
- Other IDs
- 2025-522451-25-00, 2025
- Acronym
- Probhe
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation With Botulinum Toxin A in Complex Hernia: an Italian Prospective Study on Predictive Scores of Myofascial Release.
- ClinicalTrials.gov ID
- NCT07628205
- Acronym / sponsor ID
- Probhe / 57-2024
- Conditions
- Hernia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di LegnanoUniversity, hospital or other
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 17 Feb 2029 (estimated)
- First posted
- 4 Jun 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.
In patients with large hernias, chronic retraction of the lateral abdominal wall muscles, and visceral contents that are irreducible within the hernia sac, closure of the midline can be difficult or even impossible. Component separation techniques (CST), in combination with transversus abdominis release (TAR), increase the flexibility of the abdominal wall and facilitate fascial medialization. However, these techniques alter the anatomy of the abdominal wall and are associated with higher risks of wound complications, abdominal wall disruption, and abdominal compartment syndrome (ACS).
Recently, the preoperative injection of Botulinum Toxin A (BTA) has been proposed as an effective form of chemical component separation of the muscles, or more precisely, chemical relaxation. It has been hypothesized that preoperative chemical paralysis of the lateral abdominal wall muscles through BTA increases abdominal wall compliance and facilitates fascial medialization, thereby reducing the need to resort to CST.
However, the current literature still lacks studies evaluating the impact of BTA on predictive scores for myofascial release and the correlation with intraoperative strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior Component Separation (PCS) with TAR after BTA injection. | Experimental | Procedure: Posterior Component Separation (PCS) with TAR |
| Rives-Stoppa surgery after BTA injection | Experimental | Procedure: Rives-Stoppa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant is willing and able to give informed consent for participation in the trial
- Compliance to follow-up
- Male and female
- Written informed consent to preoperative BTA injection and/or surgery
- Age 18 years old
Key exclusion criteria (11 listed)
- Medical or psychiatric conditions that compromises the patient's ability to give informed
- consent or comply with the study protocol
- Personal reasons
- Age < 18 years old
- RDR ≥ 2
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 |
|---|---|---|
| Posterior Component Separation (PCS) with TARPosterior Component Separation (PCS) with Transversus Abdominis Release (TAR) is an intraoperative surgical technique performed by the surgeon when a standard retromuscular repair, such as the Rives-Stoppa technique, does not allow for tension-free midline closure. In such cases, additional myofascial release is required, and PCS with TAR is subsequently performed to achieve adequate medial advancement of the abdominal wall components and enable secure, tension-free closure of the midline defect. | Procedure or surgery | Posterior Component Separation (PCS) with TAR after BTA injection. |
| Rives-StoppaRives-Stoppa repair is a retromuscular abdominal wall reconstruction technique used when primary fascial closure can be achieved without the need for additional myofascial release. It represents a less invasive approach compared to component separation techniques, such as Posterior Component Separation with Transversus Abdominis Release (PCS with TAR), and is performed in cases where tension-free midline closure is feasible using a standard retromuscular plane dissection. | Procedure or surgery | Rives-Stoppa surgery after BTA injection |
Primary outcome
Improvement in Preoperative Indices Following Botulinum Toxin A Injection
Time frame: Enrollment, 4 weeks after BTA injection, and 12 months after surgery
Changes in preoperative radiological indices following Botulinum Toxin A (BTA) injection will be assessed using abdominal computed tomography (CT) scans. The Rectus-to-Defect Ratio (RDR) will be calculated on pre- and post-injection CT imaging; each 0.5-point increase in RDR is associated with an approximate 20% linear reduction in the need for anterior myofascial release (AMR). The Component Separation Index (CSI) will be determined on axial CT images using the aorta as a fixed reference point and the medial borders of the rectus abdominis muscles. Abdominal cavity volume will be estimated using the ellipsoid volume formula based on craniocaudal, transverse, and anteroposterior diameters measured on CT imaging. Pre- and post-BTA values will be compared to evaluate improvement in abdominal wall compliance and anatomical reconstruction parameters.
1 secondary outcome
Association Between Changes in Preoperative Indices After Botulinum Toxin A Injection and Surgical Strategy Selection.
Time frame: until the end of the study
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 4 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Posterior Component Separation (PCS) with TAR and Rives-Stoppa in people with Hernia, run by Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano at 1 site in Italy.
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 10 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 4 Jun 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 Italy. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Preoperative Indices Following Botulinum Toxin A Injection (time frame: Enrollment, 4 weeks after BTA injection, and 12 months after surgery). 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 4 Jun 2026.