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選択的小腸切除 (MOBILE) のための機械的および口腔抗生物質の小腸切除と,小腸切除の欠如の比較:多センター,ランダム化,並行,単盲試験
Laura Koskenvuo1, Taru Lehtonen1, Selja Koskensalo1
1Department of Gastroenterological Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Lancet (London, England)
|August 13, 2019
まとめ
機械的および経口抗生物質の腸内製剤 (MOABP) は,腸内製剤 (NBP) に比べて,手術部位感染 (SSI) や結腸手術における罹患率を減少させない. コレクトミーにおけるMOABPの現在の推奨は,これらの発見に基づいて再検討されるべきである.
科学分野:
- 結腸直腸手術
- 手術による感染予防
- 胃腸の手術
背景:
- 手術部位感染 (SSI) と罹患率を減らすために,機械的および口服抗生物質の腸準備 (MOABP) が推奨されます.
- ルーティンMOABPを支持する証拠は,以前の研究に基づいており,将来的なランダム化試験での調査を促しています.
研究 の 目的:
- 選択性大腸切除手術を受けた患者のSSIおよび全般的罹患率の減少におけるMOABPの有効性を,大腸切除手術を受けていない患者 (NBP) と比較する.
- 大腸手術における MOABPの既存の推奨事項に異議を唱える.
主な方法:
- 大腸切除を受けた患者で,多センター,並列,単盲,ランダム化制御試験を実施した.
- 患者はランダムに (1:1) 割り当てられ,MOABPまたはNBPのいずれかを投与され,すべての関係者に対してマスクされた配分が行われました.
- 主なアウトカムは30日以内のSSIで,修正された治療意図アプローチを用いて分析された.
主要な成果:
- 改定された治療意図分析には合計396人の患者が含まれていた (MOABPでは196人,NBPでは200人).
- 統計的に有意な差は示されず,MOABP群の7%とNBP群の11%でSSIが発生した.
- アナストモティック解離と再手術の割合は2つのグループで類似しており,NBPグループでは2人の死亡が認められ,MOABPグループでは1人の死亡が認められなかった.
結論:
- 機械的および経口抗生物質の腸準備 (MOABP) は,腸手術における腸準備 (NBP) に比べて,手術部位感染 (SSI) または全体的な罹患率の有意な減少を示さなかった.
- この発見は,小腸切除における通常のMOABPの現在の推奨事項を再評価すべきことを示唆している.
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