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NCT Number: NCT07349628

Botulinum Toxin A Facilitates Fascial Closure in Complex Incisional Hernias

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.

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Key information

Conditions

Incisional Hernia Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aslnapoli2Nord

Naples, 80131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Radiological changes in abdominal wall morphology

    Time frame: Baseline and 5 weeks after botulinum toxin A injection

    Changes in transverse hernia defect width and lateral abdominal wall muscle elongation assessed by computed tomography before and after preoperative botulinum toxin A administration.

  2. Postoperative complications

    Time frame: Up to 30 days after surgery

    Incidence of postoperative complications, including surgical site occurrences.

  3. Length of hospital stay

    Time frame: Immediately after surgery

    Duration of postoperative hospital stay measured in days following elective hernia repair.

  4. Early hernia recurrence

    Time frame: Up to 12 months after surgery

    Occurrence of clinically or radiologically confirmed hernia recurrence during postoperative follow-up.

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Locale Napoli 2 Nord

Other

Registry information

Official study title

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

Acronym: BRIDGE-HERNIA

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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