Botulinum Toxin A Facilitates Fascial Closure in Complex Incisional Hernias

NCT07349628 | Completed

• 1 other identifier: 18992026
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Incisional Hernia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Radiological changes in abdominal wall morphology

  Baseline and 5 weeks after botulinum toxin A injection

• Postoperative complications

  Up to 30 days after surgery

• Length of hospital stay

  Immediately after surgery

• Early hernia recurrence

  Up to 12 months after surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria Locale Napoli 2 Nord: lead

Study Sites (1)

Aslnapoli2Nord

Naples, Naples, 80131, Italy

Location

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 32 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 20, 2026
• Study Start: January 1, 2021
• Primary Completion: January 1, 2025
• Study Completion: March 31, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)