Botulinum Toxins, Type ANCT06485440
The Effects of Preoperative Botulinum Toxin A Injection on Respiratory System Function
An observational study of Botulinum Toxins, Type A and Hernia, run by Swissmed Hospital at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Botulinum Toxins, Type A, Hernia
- What is being tested?
- Dysport 300 UNT Injection
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 25 Jun 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 1. Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Preoperative Botulinum Toxin A Injection Prior to Abdominal Wall Reconstruction Procedures on Respiratory System Function
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
- Conditions
- Botulinum Toxins, Type A, Hernia
- Being tested
- Dysport 300 UNT Injection
- Keywords
- BTA, Hernia, AWR, Loss of Domain, Prehabilitation, Incisional, Botulinum Toxin A
- Medical subject headings
- Hernia, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dysport 300 UNT InjectionDrug
Also called BTA Injections
300 UNITS of BTA (Dysport) injected to lateral abdominal muscles prior to abdominal wall reconstruction (4 weeks before surgery)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Dysport 300 UNT Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
FVC (forced vital capacity)
FVC before and 4-6 after BTA injection
Measured: 4-6 weeks
FEV1 (forced expiratory volume in one second)
FEV1 before and 4-6 after BTA injection
Measured: 4-6 weeks
PEF (peak expiratory flow)
PEF before and 4-6 after BTA injection
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start25 Jun 2024
- Primary completion1 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Botulinum Toxins, Type AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swissmed Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mateusz Zamkowski, Swissmed Hospital
- Investigators
- Maciej Śmietański, MD, PhD, Prof., Study director, Swissmed HospitalMateusz Zamkowski, MD, PhD, Study chair, Swissmed Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485440
- Sponsor's protocol ID
- BTA Impact
- Status last verified
- Feb 2026
- First submitted
- 25 Jun 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared on justified cases.
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 26951247Timmer 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 34546475Weissler 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 28277071Whitehead-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 34660688Zendejas 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 24081529Spiesshoefer 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Preoperative Botulinum Toxin A Injection Prior to Abdominal Wall Reconstruction Procedures on Respiratory System Function
- ClinicalTrials.gov ID
- NCT06485440
- Acronym / sponsor ID
- BTA Impact
- Conditions
- Botulinum Toxins, Type A, Hernia
- Keywords
- BTA, Hernia, AWR, Loss of Domain, Prehabilitation, Incisional, Botulinum Toxin A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Swissmed HospitalUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BTA | – | Drug: Dysport 300 UNT Injection10 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Refusal to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dysport 300 UNT InjectionAlso: BTA Injections300 UNITS of BTA (Dysport) injected to lateral abdominal muscles prior to abdominal wall reconstruction (4 weeks before surgery) | Drug | BTA |
Primary outcome
FVC (forced vital capacity)
Time frame: 4-6 weeks
FVC before and 4-6 after BTA injection
FEV1 (forced expiratory volume in one second)
Time frame: 4-6 weeks
FEV1 before and 4-6 after BTA injection
PEF (peak expiratory flow)
Time frame: 4-6 weeks
PEF before and 4-6 after BTA injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Results publication: PubMed 26951247Elstner 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.
- Results publication: PubMed 34546475Timmer 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.
- Results publication: PubMed 28277071Weissler 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.
- Results publication: PubMed 34660688Whitehead-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.
- Results publication: PubMed 24081529Zendejas 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.
- Results publication: PubMed 32396905Spiesshoefer 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.
- Individual participant dataSharing planned: Undecided. Data will be shared on justified cases.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maciej Śmietański, MD, PhD, Prof. study director
Swissmed Hospital
Mateusz Zamkowski, MD, PhD study chair
Swissmed Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Botulinum Toxins, Type A and Hernia, run by Swissmed Hospital at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FVC (forced vital capacity) (time frame: 4-6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06485440, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.