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

February 5, 2026 updated by: Mateusz Zamkowski, Swissmed Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Gdańsk
      • Gdansk, Gdańsk, Poland, 80-215
        • Swissmed Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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:

1. Refusal to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
300 UNITS of BTA (Dysport) injected to lateral abdominal muscles prior to abdominal wall reconstruction (4 weeks before surgery)
Other Names:
  • BTA Injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FVC (forced vital capacity)
Time Frame: 4-6 weeks
FVC before and 4-6 after BTA injection
4-6 weeks
FEV1 (forced expiratory volume in one second)
Time Frame: 4-6 weeks
FEV1 before and 4-6 after BTA injection
4-6 weeks
PEF (peak expiratory flow)
Time Frame: 4-6 weeks
PEF before and 4-6 after BTA injection
4-6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
MEF (Maximal Mid Expiratory Flow)
Time Frame: 4-6 weeks
MEF before and 4-6 after BTA injection
4-6 weeks
FIVC (Forced Inspiratory Vital Capacity)
Time Frame: 4-6 weeks
FIVC before and 4-6 after BTA injection
4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swissmed Hospital

Investigators

  • Study Chair: Mateusz Zamkowski, MD, PhD, Swissmed Hospital
  • Study Director: Maciej Śmietański, MD, PhD, Prof., Swissmed Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2024

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

June 29, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTA Impact

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be shared on justified cases.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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