Incisional HerniaBRIDGE-HERNIANCT07349628
Botulinum Toxin A Facilitates Fascial Closure in Complex Incisional Hernias
An observational study of Incisional Hernia, run by Azienda Sanitaria Locale Napoli 2 Nord at 1 site in Italy.
Trial summary
Brief Study Description This prospective observational study evaluates the use of preoperative botulinum toxin A as part of a structured clinical pathway for patients undergoing elective repair of complex midline incisional hernias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 31 Mar 2025
- How long will I take part?
- 32 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: * Emergency hernia repair * Lateral or non-midline incisional hernia * Presence of true loss of domain requiring alternative surgical strategies * Previous allergic reaction or contraindication to botulinum toxin A * Neuromuscular disorders contraindicating botulinum toxin administration * Pregnancy or breastfeeding * Inability to comply with planned follow-up schedule
Who may be able to join
- Age 18 years or older
- Diagnosis of complex midline incisional hernia
- Planned elective surgical repair of the incisional hernia
- Preoperative management including botulinum toxin A administration as part of routine clinical care
- Ability to undergo contrast-enhanced computed tomography imaging
- Ability to provide written informed consent
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Botulinum Toxin A Enables Fascial Closure and Reduces Morbidity in Complex Incisional Hernias: Results From the Prospective
Brief Study Description
This prospective observational study evaluates the use of preoperative botulinum toxin A as part of a structured clinical pathway for patients undergoing elective repair of complex midline incisional hernias. Botulinum toxin A is administered before surgery to temporarily relax the abdominal wall muscles, with the aim of improving abdominal wall flexibility and facilitating closure of the hernia without the need for more extensive surgical techniques. The study collects clinical, radiological, and postoperative outcome data to assess surgical feasibility, complications, and early recurrence. The overall goal is to better understand how preoperative muscle relaxation may support safer and more effective abdominal wall reconstruction.
Read the detailed description
Detailed Description
This prospective observational study investigates a preoperative strategy designed to improve surgical outcomes in patients with complex midline incisional hernias. These hernias often involve large abdominal wall defects and significant muscle retraction, which can make surgical repair difficult and increase the risk of complications. To address these challenges, the study evaluates the use of botulinum toxin A administered before surgery as part of a standardized clinical pathway known as the BRIDGE-HERNIA protocol.
Botulinum toxin A is injected into the lateral abdominal wall muscles several weeks before the planned operation. Its temporary muscle-relaxing effect increases the flexibility of the abdominal wall, which may allow surgeons to close the hernia defect more easily and avoid more invasive surgical techniques. All patients undergo detailed preoperative assessment, including imaging studies, to evaluate abdominal wall anatomy and to plan the surgical approach. After botulinum toxin administration, imaging is repeated to assess changes in muscle length and hernia dimensions.
The study prospectively collects clinical, radiological, surgical, and postoperative data. Primary outcomes include the feasibility of achieving direct fascial closure without advanced component separation techniques. Secondary outcomes include postoperative complications, length of hospital stay, early hernia recurrence, and patient-reported quality of life. Because the study is observational, all treatments are delivered according to routine clinical practice, and no additional experimental interventions are assigned by the study protocol.
The results of this study aim to improve understanding of how preoperative muscle relaxation can support safer and less invasive surgical repair of complex incisional hernias, and to provide evidence that may help optimize surgical planning and patient selection in abdominal wall reconstruction.
- Conditions
- Incisional Hernia
- Keywords
- Complex incisional hernia, Ventral hernia repair, Abdominal wall reconstruction, Botulinum toxin injection, Prehabilitation
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with complex midline incisional hernia | his cohort includes adult patients with complex midline incisional hernias undergoing elective surgical repair within a standardized clinical pathway that incorporates preoperative botulinum toxin A administration. Participants are prospectively followed to collect clinical, radiological, surgical, and postoperative outcome data as part of routine clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of fascial closure without transversus abdominis release
The proportion of patients in whom midline fascial closure is achieved using the Rives-Stoppa technique without the need for transversus abdominis release during elective repair of complex midline incisional hernias following preoperative botulinum toxin A administration.
Measured: During surgery (index procedure)
Secondary outcomes (4)
Radiological changes in abdominal wall morphology
Changes in transverse hernia defect width and lateral abdominal wall muscle elongation assessed by computed tomography before and after preoperative botulinum toxin A administration.
Measured: Baseline and 5 weeks after botulinum toxin A injection
Postoperative complications
Incidence of postoperative complications, including surgical site occurrences.
Measured: Up to 30 days after surgery
Length of hospital stay
Duration of postoperative hospital stay measured in days following elective hernia repair.
Measured: Immediately after surgery
Early hernia recurrence
Occurrence of clinically or radiologically confirmed hernia recurrence during postoperative follow-up.
Measured: Up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jan 2021
- Primary completion1 Jan 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
- Target duration
- 32 Years
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale Napoli 2 Nord
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pizza, Azienda Sanitaria Locale Napoli 2 Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349628
- Sponsor's protocol ID
- 18992026
- Acronym
- BRIDGE-HERNIA
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. This study is a single-center prospective observational cohort with a limited sample size, and the collected clinical and imaging data may contain potentially identifiable information. No formal data-sharing plan was included in the original study protocol, and no approval for external data sharing was obtained from the local ethics committee. Aggregate data are reported in publications, and additional information may be considered upon reasonable request and subject to institutional and ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Botulinum Toxin A Enables Fascial Closure and Reduces Morbidity in Complex Incisional Hernias: Results From the Prospective
- ClinicalTrials.gov ID
- NCT07349628
- Acronym / sponsor ID
- BRIDGE-HERNIA / 18992026
- Conditions
- Incisional Hernia
- Keywords
- Complex incisional hernia, Ventral hernia repair, Abdominal wall reconstruction, Botulinum toxin injection, Prehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Azienda Sanitaria Locale Napoli 2 NordUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 20 Jan 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.
Brief Study Description
This prospective observational study evaluates the use of preoperative botulinum toxin A as part of a structured clinical pathway for patients undergoing elective repair of complex midline incisional hernias. Botulinum toxin A is administered before surgery to temporarily relax the abdominal wall muscles, with the aim of improving abdominal wall flexibility and facilitating closure of the hernia without the need for more extensive surgical techniques. The study collects clinical, radiological, and postoperative outcome data to assess surgical feasibility, complications, and early recurrence. The overall goal is to better understand how preoperative muscle relaxation may support safer and more effective abdominal wall reconstruction.
Detailed description
Detailed Description
This prospective observational study investigates a preoperative strategy designed to improve surgical outcomes in patients with complex midline incisional hernias. These hernias often involve large abdominal wall defects and significant muscle retraction, which can make surgical repair difficult and increase the risk of complications. To address these challenges, the study evaluates the use of botulinum toxin A administered before surgery as part of a standardized clinical pathway known as the BRIDGE-HERNIA protocol.
Botulinum toxin A is injected into the lateral abdominal wall muscles several weeks before the planned operation. Its temporary muscle-relaxing effect increases the flexibility of the abdominal wall, which may allow surgeons to close the hernia defect more easily and avoid more invasive surgical techniques. All patients undergo detailed preoperative assessment, including imaging studies, to evaluate abdominal wall anatomy and to plan the surgical approach. After botulinum toxin administration, imaging is repeated to assess changes in muscle length and hernia dimensions.
The study prospectively collects clinical, radiological, surgical, and postoperative data. Primary outcomes include the feasibility of achieving direct fascial closure without advanced component separation techniques. Secondary outcomes include postoperative complications, length of hospital stay, early hernia recurrence, and patient-reported quality of life. Because the study is observational, all treatments are delivered according to routine clinical practice, and no additional experimental interventions are assigned by the study protocol.
The results of this study aim to improve understanding of how preoperative muscle relaxation can support safer and less invasive surgical repair of complex incisional hernias, and to provide evidence that may help optimize surgical planning and patient selection in abdominal wall reconstruction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 32 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with complex midline incisional hernia | – | –his cohort includes adult patients with complex midline incisional hernias undergoing elective surgical repair within a standardized clinical pathway that incorporates preoperative botulinum toxin A administration. Participants are prospectively followed to collect clinical, radiological, surgical, and postoperative outcome data as part of routine clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Emergency hernia repair * Lateral or non-midline incisional hernia * Presence of true loss of domain requiring alternative surgical strategies * Previous allergic reaction or contraindication to botulinum toxin A * Neuromuscular disorders contraindicating botulinum toxin administration * Pregnancy or breastfeeding * Inability to comply with planned follow-up schedule
Key inclusion criteria (6 listed)
- Age 18 years or older
- Diagnosis of complex midline incisional hernia
- Planned elective surgical repair of the incisional hernia
- Preoperative management including botulinum toxin A administration as part of routine clinical care
- Ability to undergo contrast-enhanced computed tomography imaging
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of fascial closure without transversus abdominis release
Time frame: During surgery (index procedure)
The proportion of patients in whom midline fascial closure is achieved using the Rives-Stoppa technique without the need for transversus abdominis release during elective repair of complex midline incisional hernias following preoperative botulinum toxin A administration.
4 secondary outcomes
Radiological changes in abdominal wall morphology
Time frame: Baseline and 5 weeks after botulinum toxin A injection
Postoperative complications
Time frame: Up to 30 days after surgery
Length of hospital stay
Time frame: Immediately after surgery
Early hernia recurrence
Time frame: Up to 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. This study is a single-center prospective observational cohort with a limited sample size, and the collected clinical and imaging data may contain potentially identifiable information. No formal data-sharing plan was included in the original study protocol, and no approval for external data sharing was obtained from the local ethics committee. Aggregate data are reported in publications, and additional information may be considered upon reasonable request and subject to institutional and ethical approval.
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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. This study is not recruiting at the moment.
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?
An observational study of Incisional Hernia, run by Azienda Sanitaria Locale Napoli 2 Nord 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 6 inclusion and 1 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: finished, as of the sponsor's last update on 20 Jan 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of fascial closure without transversus abdominis release (time frame: During surgery (index procedure)). 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 20 Jan 2026.