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Preoperative Botulinum Toxin A to Facilitate Midline Closure in Large Chronic Ventral Hernias (Probhe)

3. juni 2026 opdateret af: Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano

Prehabilitation With Botulinum Toxin A in Complex Hernia: an Italian Prospective Study on Predictive Scores of Myofascial Release.

In patients with large hernias, chronic retraction of the lateral abdominal wall muscles, and visceral contents that are irreducible within the hernia sac, closure of the midline can be difficult or even impossible. Component separation techniques (CST), in combination with transversus abdominis release (TAR), increase the flexibility of the abdominal wall and facilitate fascial medialization. However, these techniques alter the anatomy of the abdominal wall and are associated with higher risks of wound complications, abdominal wall disruption, and abdominal compartment syndrome (ACS).

Recently, the preoperative injection of Botulinum Toxin A (BTA) has been proposed as an effective form of chemical component separation of the muscles, or more precisely, chemical relaxation. It has been hypothesized that preoperative chemical paralysis of the lateral abdominal wall muscles through BTA increases abdominal wall compliance and facilitates fascial medialization, thereby reducing the need to resort to CST.

However, the current literature still lacks studies evaluating the impact of BTA on predictive scores for myofascial release and the correlation with intraoperative strategies.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

44

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Italien
    • Milano
      • Legnano, Milano, Italien, 20025
        • Asst Ovest Milanese

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the trial
  • Compliance to follow-up
  • Male and female
  • Written informed consent to preoperative BTA injection and/or surgery
  • Age 18 years old
  • Primary ventral hernia
  • Incisional ventral hernia
  • RDR < 2
  • Defect width 10 cm
  • Loss of domain (LoD) 20%

Exclusion Criteria:

  • Medical or psychiatric conditions that compromises the patient's ability to give informed
  • consent or comply with the study protocol
  • Personal reasons
  • Age < 18 years old
  • RDR ≥ 2
  • Defect width < 10 cm
  • LoD < 20%
  • Pregnancy and breastfeeding
  • Allergy/Intolerance to BTA
  • Neuromuscular disorders and diseases
  • Refuse to give informed consent to preoperative BTA injection and/or surgery

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Posterior Component Separation (PCS) with TAR after BTA injection.
Procedure: Posterior Component Separation (PCS) with TAR
Posterior Component Separation (PCS) with Transversus Abdominis Release (TAR) is an intraoperative surgical technique performed by the surgeon when a standard retromuscular repair, such as the Rives-Stoppa technique, does not allow for tension-free midline closure. In such cases, additional myofascial release is required, and PCS with TAR is subsequently performed to achieve adequate medial advancement of the abdominal wall components and enable secure, tension-free closure of the midline defect.
Eksperimentel: Rives-Stoppa surgery after BTA injection
Procedure: Rives-Stoppa
Rives-Stoppa repair is a retromuscular abdominal wall reconstruction technique used when primary fascial closure can be achieved without the need for additional myofascial release. It represents a less invasive approach compared to component separation techniques, such as Posterior Component Separation with Transversus Abdominis Release (PCS with TAR), and is performed in cases where tension-free midline closure is feasible using a standard retromuscular plane dissection.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Improvement in Preoperative Indices Following Botulinum Toxin A Injection
Tidsramme: Enrollment, 4 weeks after BTA injection, and 12 months after surgery
Changes in preoperative radiological indices following Botulinum Toxin A (BTA) injection will be assessed using abdominal computed tomography (CT) scans. The Rectus-to-Defect Ratio (RDR) will be calculated on pre- and post-injection CT imaging; each 0.5-point increase in RDR is associated with an approximate 20% linear reduction in the need for anterior myofascial release (AMR). The Component Separation Index (CSI) will be determined on axial CT images using the aorta as a fixed reference point and the medial borders of the rectus abdominis muscles. Abdominal cavity volume will be estimated using the ellipsoid volume formula based on craniocaudal, transverse, and anteroposterior diameters measured on CT imaging. Pre- and post-BTA values will be compared to evaluate improvement in abdominal wall compliance and anatomical reconstruction parameters.
Enrollment, 4 weeks after BTA injection, and 12 months after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Association Between Changes in Preoperative Indices After Botulinum Toxin A Injection and Surgical Strategy Selection.
Tidsramme: until the end of the study
Two surgical strategies will be considered based on abdominal wall reconstruction requirements: (A) Posterior Component Separation (PCS) with Transversus Abdominis Release (TAR), and (B) Rives-Stoppa repair, performed when no myofascial release is required. For PCS with TAR procedures, the Posterior Bridging Ratio (PBR) and Anterior Bridging Ratio (ABR) will be assessed as the proportion of the peritoneal sac used as a bridge to achieve tension-free closure of the posterior and anterior fascial layers, respectively. The extent of ABR and PBR will be analyzed in relation to the preoperative effect of Botulinum Toxin A (BTA) injection. In particular, higher percentages (>50%) of PBR and ABR will be considered indicative of poor BTA efficacy, intermediate values (25-50%) of partial efficacy, and low values (0-25%) of good to very good BTA efficacy. The relationship between changes in preoperative indices after BTA administration and the selected surgical approach will be evaluated.
until the end of the study

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. februar 2026

Primær færdiggørelse (Anslået)

1. januar 2029

Studieafslutning (Anslået)

17. februar 2029

Datoer for studieregistrering

Først indsendt

14. maj 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 57-2024
  • 2025-522451-25-00 (Ctis)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Brok

Kliniske forsøg med Posterior Component Separation (PCS) with TAR

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