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The Effects of Preoperative Botulinum Toxin A Injection on Respiratory System Function

NCT06485440 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-02-06

No results posted yet for this study

Summary

Hernias are common complications post-abdominal surgeries, often leading to significant issues such as "loss of domain," where organs shift permanently, reducing abdominal cavity capacity. This complicates surgeries as there is insufficient space to reposition organs. A growing method to address this involves preoperative botulinum toxin A (BTA) injections into lateral abdominal muscles. BTA induces temporary paralysis, expanding the abdominal cavity and aiding muscle approximation for hernia repair. Initiated in 2009, this approach is particularly used for defects over 10cm. However, standardized protocols are lacking, and the impact on respiratory function remains under-researched. This study aims to evaluate the effects of preoperative BTA injections on respiratory volumes. Ten patients will undergo pulmonary function tests before and after BTA injections. The study will focus on changes in respiratory efficiency, given the respiratory challenges associated with large hernias and the "loss of domain" effect.

Conditions

  • Botulinum Toxins, Type A
  • Hernia

Interventions

DRUG

Dysport 300 UNT Injection

300 UNITS of BTA (Dysport) injected to lateral abdominal muscles prior to abdominal wall reconstruction (4 weeks before surgery)

Sponsors & Collaborators

  • Swissmed Hospital

    lead OTHER

Principal Investigators

  • Maciej Śmietański, MD, PhD, Prof. · Swissmed Hospital

  • Mateusz Zamkowski, MD, PhD · Swissmed Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-25
Primary Completion
2025-01-01
Completion
2025-03-01
FDA Drug
Yes

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06485440 on ClinicalTrials.gov