Botulinum Toxin A Facilitates Fascial Closure in Complex Incisional Hernias (BRIDGE-HERNIA)

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.

Study Overview

• Status: Completed
• Conditions: Incisional Hernia

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 Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Italy
  • Naples
    • Naples, Naples, Italy, 80131
      • Aslnapoli2Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

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:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During surgery (index procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 5 weeks after botulinum toxin A injection
Postoperative complications	Incidence of postoperative complications, including surgical site occurrences.	Up to 30 days after surgery
Length of hospital stay	Duration of postoperative hospital stay measured in days following elective hernia repair.	Immediately after surgery
Early hernia recurrence	Occurrence of clinically or radiologically confirmed hernia recurrence during postoperative follow-up.	Up to 12 months after surgery

Collaborators and Investigators

• Sponsor: Azienda Sanitaria Locale Napoli 2 Nord

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Prehabilitation; Abdominal wall reconstruction; Botulinum toxin injection; Ventral hernia repair; Complex incisional hernia
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Hernia; Pathological Conditions, Signs and Symptoms; Incisional Hernia
• Other Study ID Numbers: 18992026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No