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

Azienda Sanitaria Locale Napoli 2 Nord

Status: Completed

Conditions: Incisional Hernia

Study type: Observational

Funder types: Other

Identifiers

NCT07349628

18992026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

-

Trial design

32 participants in 1 patient group

Patients with complex midline incisional hernia

Description:

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.