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Botulinum Toxin A Facilitates Fascial Closure in Complex Incisional Hernias

Preoperative Botulinum Toxin A Enables Fascial Closure and Reduces Morbidity in Complex Incisional Hernias: Results From the Prospective

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07349628
Acronym
BRIDGE-HERNIA
Enrollment
32
Registered
2026-01-20
Start date
2021-01-01
Completion date
2025-03-31
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incisional Hernia

Keywords

Complex incisional hernia, Ventral hernia repair, Abdominal wall reconstruction, Botulinum toxin injection, Prehabilitation

Brief 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. 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.

Interventions

None listed

Sponsors

Azienda Sanitaria Locale Napoli 2 Nord
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Rate of fascial closure without transversus abdominis releaseDuring 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.

Secondary

MeasureTime frameDescription
Radiological changes in abdominal wall morphologyBaseline and 5 weeks after botulinum toxin A injectionChanges in transverse hernia defect width and lateral abdominal wall muscle elongation assessed by computed tomography before and after preoperative botulinum toxin A administration.
Postoperative complicationsUp to 30 days after surgeryIncidence of postoperative complications, including surgical site occurrences.
Length of hospital stayImmediately after surgeryDuration of postoperative hospital stay measured in days following elective hernia repair.
Early hernia recurrenceUp to 12 months after surgeryOccurrence of clinically or radiologically confirmed hernia recurrence during postoperative follow-up.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026