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CompletedNCT06485440Updated Feb 6, 2026

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

An observational study in Botulinum Toxins, Type A and Hernia, sponsored by Swissmed Hospital. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by Swissmed Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

Hernias are frequent complications following abdominal procedures, particularly in cases of large defects which may lead to the "loss of domain" effect. This phenomenon involves permanent displacement of organs into an alternative space, reducing the effective capacity of the peritoneal cavity. Surgical management of giant hernial sacs is challenging due to insufficient space within the abdominal cavity to accommodate organ repositioning.

Abdominal wall reconstruction specialists have developed various techniques to address these complexities. One increasingly utilized method involves the injection of botulinum toxin A (BTA) into the lateral abdominal muscles (external oblique, internal oblique, and transverse muscles). BTA induces temporary muscular paralysis lasting approximately 6-8 months. This paralysis extends the muscle compartment, thereby increasing abdominal cavity volume. This expansion facilitates the approximation of rectus abdominis muscles and the closure of fascial defects.

Initial attempts to employ BTA for the treatment of giant abdominal hernias began in 2009. Since then, its role in abdominal wall surgery has grown steadily. Optimal timing for surgery post-BTA injection is typically 3-4 weeks, when maximal muscle extension and abdominal volume increase (up to 20-30%) are observed.

Despite widespread clinical use, standardized protocols for BTA application remain lacking due to limited comparative studies and small sample sizes in existing literature. Rare allergic reactions aside, comprehensive documentation of adverse effects from BTA injections remains minimal. However, variability in patient response suggests potential differences in treatment efficacy.

Respiratory efficiency poses a significant challenge in patients with giant abdominal hernias, exacerbated by the "loss of domain" effect which impairs diaphragm function and alters respiratory mechanics. Predicting perioperative outcomes is further complicated by advanced age, comorbidities, and obesity among affected patients.

To investigate the impact of preoperative BTA injection on respiratory function, a study will assess pulmonary volumes using spirometry in 10 patients with giant hernias of the anterior abdominal wall (classified as W3 by the European Hernia Society). Participants will undergo spirometry before and 4 weeks after lateral muscle group BTA injection as part of preoperative evaluation for abdominal wall reconstruction at the Swissmed Hospital Hernia Centre in Gdansk.

The injection of BTA will be performed in outpatient settings, under ultrasound guidance. Each patient received 300 units of BTA (Dysport®, IPSEN, Boulogne-Billancourt, France), with 150 units administered to each side. The BTA administration procedure will begin with drawing lines on the skin to mark the lower edge of the last rib and the upper edge of the iliac crest. Then, a line connecting both marked sections is drawn along the anterior axillary line. On this line, three equally spaced points will be marked. These will be the sites for needle insertion and BTA administration. 300 units of BTA will be dissolved in 150ml of 0.9% saline. This solution will be then divided into six 25ml portions. Each portion is administered at the previously designated points. During the injection at a point, under ultrasound control, we reach the transverse muscle and administer 8ml of the solution. Then, the needle will be withdrawn to the internal oblique muscle, and another 8ml is administered. Finally, the needle will be withdrawn to the level of the external oblique muscle, where the remaining portion of the dose is administered. This procedure is repeated at each point

02

Conditions studied

  • Botulinum Toxins, Type A
  • Hernia

Keywords

  • BTA
  • Hernia
  • AWR
  • Loss of Domain
  • Prehabilitation
  • Incisional
  • Botulinum Toxin A
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In context

Hernia

257 studies on the registry are indexed under Hernia; 37 are open to participants now.

This study's enrollment of 30 is below the median of 120 across 85 observational studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

Swissmed Hospital is the lead sponsor of 8 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

1. Refusal to participate in the study.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DrugDysport 300 UNT Injection

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

    Also known as: BTA Injections

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What researchers measure

Primary outcomes

  1. FVC (forced vital capacity)

    FVC before and 4-6 after BTA injection

    Time frame: 4-6 weeks

  2. FEV1 (forced expiratory volume in one second)

    FEV1 before and 4-6 after BTA injection

    Time frame: 4-6 weeks

  3. PEF (peak expiratory flow)

    PEF before and 4-6 after BTA injection

    Time frame: 4-6 weeks

Other outcomes

  1. MEF (Maximal Mid Expiratory Flow)

    MEF before and 4-6 after BTA injection

    Time frame: 4-6 weeks

  2. FIVC (Forced Inspiratory Vital Capacity)

    FIVC before and 4-6 after BTA injection

    Time frame: 4-6 weeks

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Study locations

1 site
  • Swissmed Hospital
    Gdansk, Gdańsk 80-215, Poland
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References and documents

Publications

  • 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. PubMed 26951247 ↗
  • 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. PubMed 34546475 ↗
  • 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. PubMed 28277071 ↗
  • 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. PubMed 34660688 ↗
  • 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. PubMed 24081529 ↗
  • 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. PubMed 32396905 ↗

Individual participant data

Plan to share: Undecided — Data will be shared on justified cases.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06485440
Lead sponsor
Swissmed Hospital
Responsible party
Mateusz Zamkowski (Principal Investigator, Director, Swissmed Hospital) — Principal investigator
First posted
Jul 3, 2024
Start date
Jun 25, 2024
Primary completion
Jan 1, 2025
Completion
Mar 1, 2025
Last update
Feb 6, 2026

Study contacts

Maciej Śmietański, MD, PhD, Prof.
study director · Swissmed Hospital
Mateusz Zamkowski, MD, PhD
study chair · Swissmed Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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