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

NCT06485440 | Completed FDA Drug

• 1 other identifier: BTA Impact
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

BTA; Hernia; AWR; Loss of Domain; Prehabilitation; Incisional; Botulinum Toxin A

Outcome Measures

Primary Outcomes (3)

• FVC (forced vital capacity)

  FVC before and 4-6 after BTA injection

  4-6 weeks

• FEV1 (forced expiratory volume in one second)

  FEV1 before and 4-6 after BTA injection

  4-6 weeks

• PEF (peak expiratory flow)

  PEF before and 4-6 after BTA injection

  4-6 weeks

Other Outcomes (2)

• MEF (Maximal Mid Expiratory Flow)

  4-6 weeks

• FIVC (Forced Inspiratory Vital Capacity)

  4-6 weeks

Study Arms (1)

BTA

10 patients with giant hernias of the anterior abdominal wall (W3 in the classification of the European Hernia Society) prepared with BTA injections prior to surgery

Drug: Dysport 300 UNT Injection

Interventions

Dysport 300 UNT Injection DRUG

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

Also known as: BTA Injections

BTA

Eligibility Criteria

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

Study Population

10 patients with giant hernias of the anterior abdominal wall (W3 in the classification of the European Hernia Society) will be included in this study. Patients qualified for the reconstruction of the anterior abdominal wall, qualified by an expert team from the Hernia Centre (Swissmed Hospital in Gdansk) and meeting the inclusion criteria for the study. Each patient, as part of preoperative preparation, will have pulmonary function tests performed twice, i.e., spirometry, before and 4 weeks after injecting the lateral muscle groups with BTA.

You may qualify if:

• Large abdominal hernia (at least W3 in the EHS classification), requiring additional preoperative techniques to prevent ACS (abdominal compartment syndrome) in the postoperative period.
• Age \>18 years.
• Written consent to participate in the study.
• Health status allowing the safe conduct of surgery.

You may not qualify if:

• \. Refusal to participate in the study.

Sponsors & Collaborators

• Swissmed Hospital: lead

Study Sites (1)

Swissmed Hospital

Gdansk, Gdańsk, 80-215, Poland

Location

Related Publications (6)

• Elstner KE, Jacombs AS, Read JW, Rodriguez O, Edye M, Cosman PH, Dardano AN, Zea A, Boesel T, Mikami DJ, Craft C, Ibrahim N. Laparoscopic repair of complex ventral hernia facilitated by pre-operative chemical component relaxation using Botulinum Toxin A. Hernia. 2016 Apr;20(2):209-19. doi: 10.1007/s10029-016-1478-6. Epub 2016 Mar 7.

  PMID: 26951247 RESULT

• Timmer AS, Claessen JJM, Atema JJ, Rutten MVH, Hompes R, Boermeester MA. A systematic review and meta-analysis of technical aspects and clinical outcomes of botulinum toxin prior to abdominal wall reconstruction. Hernia. 2021 Dec;25(6):1413-1425. doi: 10.1007/s10029-021-02499-1. Epub 2021 Sep 21.

  PMID: 34546475 RESULT

• Weissler JM, Lanni MA, Tecce MG, Carney MJ, Shubinets V, Fischer JP. Chemical component separation: a systematic review and meta-analysis of botulinum toxin for management of ventral hernia. J Plast Surg Hand Surg. 2017 Oct;51(5):366-374. doi: 10.1080/2000656X.2017.1285783. Epub 2017 Feb 20.

  PMID: 28277071 RESULT

• Whitehead-Clarke T, Windsor A. The Use of Botulinum Toxin in Complex Hernia Surgery: Achieving a Sense of Closure. Front Surg. 2021 Oct 1;8:753889. doi: 10.3389/fsurg.2021.753889. eCollection 2021.

  PMID: 34660688 RESULT

• Zendejas B, Khasawneh MA, Srvantstyan B, Jenkins DH, Schiller HJ, Zielinski MD. Outcomes of chemical component paralysis using botulinum toxin for incisional hernia repairs. World J Surg. 2013 Dec;37(12):2830-7. doi: 10.1007/s00268-013-2211-6.

  PMID: 24081529 RESULT

• Spiesshoefer J, Herkenrath S, Henke C, Langenbruch L, Schneppe M, Randerath W, Young P, Brix T, Boentert M. Evaluation of Respiratory Muscle Strength and Diaphragm Ultrasound: Normative Values, Theoretical Considerations, and Practical Recommendations. Respiration. 2020;99(5):369-381. doi: 10.1159/000506016. Epub 2020 May 12.

  PMID: 32396905 RESULT

MeSH Terms

Conditions

Hernia; Surgical Wound

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Maciej Śmietański, MD, PhD, Prof.

  Swissmed Hospital

  STUDY DIRECTOR

• Mateusz Zamkowski, MD, PhD

  Swissmed Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 3, 2024
• Study Start: June 25, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

PL (1)