Preoperative Botulinum Toxin A to Facilitate Midline Closure in Large Chronic Ventral Hernias (Probhe)
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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究場所
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Milano
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Legnano、Milano、イタリア、20025
- Asst Ovest Milanese
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Posterior Component Separation (PCS) with TAR after BTA injection.
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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.
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実験的：Rives-Stoppa surgery after BTA injection
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Improvement in Preoperative Indices Following Botulinum Toxin A Injection
時間枠：Enrollment, 4 weeks after BTA injection, and 12 months after surgery
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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.
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Enrollment, 4 weeks after BTA injection, and 12 months after surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Association Between Changes in Preoperative Indices After Botulinum Toxin A Injection and Surgical Strategy Selection.
時間枠：until the end of the study
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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.
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until the end of the study
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 57-2024
- 2025-522451-25-00 (Ctis)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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ヘルニアの臨床試験
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Hospital San Juan de Dios Tenerife募集