| 摘要: | 研究動機與目的：
結直腸手術部位傷口有很高的感染風險，臨床上為降低手術部位傷口感染率，將負壓傷口治療(Negative pressure wound treatment, NPWT)應用在手術後傷口治療效果已逐漸被重視，目前已廣泛運用在骨科、血管外科、心臟胸腔外科、整形外科或腹部手術後傷口，其傷口感染率都有顯著的改善。然而，最近於結直腸外科領域發表的幾篇隨機對照試驗，使用負壓傷口治療方式於手術部位傷口為降低其感染率，但結果並不一致。因此本研究運用系統性文獻回顧與統合分析法，評估負壓傷口治療對於結直腸手術術後傷口感染控制之成效。
研究設計：
依關鍵字搜尋1986?至2022?2月發表於Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, CINAHL, and Clinical trial registration等5種電子資?庫進?文獻搜尋。將符合納入準則之隨機對照試驗使用考科藍誤差風險評估工具(Cochrane Collaboration risk of bias tool; RoB 2.0)來評估研究的品質，對於世代研究的品質，使用紐卡索渥太華品質評估量表(Newcastle-Ottawa scale)評估，依照證據等級與建議強度評比系統評估證據確定性。運用隨機效應模式，以勝算比、平均差與百分之九十五信賴區間估計研究相關性的強度。透過異質性、敏感度、次族群與發表偏誤來評估本研究結果的穩定性。擷取後之資料採用RevMan 5.4軟體進行統合分析，以檢視負壓傷口治療對於結直腸手術術後傷口感染控制之成效。
研究結果：
總共納入2,193位病人，分析的文章了有五項隨機對照試驗和六項非隨機對照試驗。使用負壓傷口治療組(NPWT)與標準敷料組相比其手術部位傷口感染(Surgical site infection, SSI) (勝算比，0.57; 95%信賴區間，0.41 to 0.78; 異質性，14%)與整體傷口併發症(Overall wound complications) (勝算比，0.33; 95%信賴區間，0.13 to 0.88; 異質性，59%)風險顯著降低，負壓傷口治療組其傷口癒合時間(Mean complete wound healing time)較標準敷料組快了將近3天(平均差，?2.98; 95%信賴區間， ?4.99 to ?0.97; 異質性，0%)；發生傷口出血(Bleeding)、血腫(Hematoma)的風險、住院天數(Length of hospital stay, LOHS)、再入院與再次接受手術比率和死亡率於兩組之間沒有顯著差異。隨機對照試驗(RCT)研究結果呈現運用負壓傷口治療(NPWT)無法降低手術部位傷口感染(SSI)風險，經敏感度分析後結果不變。在亞組分析中，運用負壓傷口治療於擇期與緊急手術(elective and emergency surgery)的病人都有顯著效益;依照傷口分類發現負壓傷口治療的介入，於擇期手術(elective surgery)、清淨污染傷口(clean-contaminated)與造口閉合(stoma reversal)手術傷口沒有顯著的效果，而污染傷口(contaminated)至骯髒傷口(dirty wound)手術傷口感染風險(SSI)顯著降低。
結論：
負壓傷口治療的介入顯著降低了結直腸病人於手術部位傷口感染風險，在未增加整體傷口併發症(Overall wound complications)風險的前提之下，使用負壓傷口治療的同時縮短了傷口癒合的時間(Complete wound healing time)。在亞組分析中，使用負壓傷口治療於擇期與危及生命的緊急手術的病人、傷口分類為污染性傷口(contaminated)至骯髒傷口(dirty wound)似乎有更好的效果。因此需要更多隨機對照試驗的證據，以確保應用負壓傷口治療後能有效降低手術部位傷口感染風險，為接受結直腸手術病人提供最佳治療方案。
Background:
Colorectal surgery has a high risk of wound infection. Negative pressure wound treatment (NPWT) has demonstrated promising results for the reducing of surgical site infection (SSIs) rate after orthopedic, vascular, cardiothoracic, plastic, and abdominal surgery. In the field of colorectal surgery, the literature on NPWT for colorectal incisions is growing, with several randomized controlled trials (RCTs) published recently, but findings have been inconsistent. We evaluated the effectiveness and safety of NPWT for colorectal incisions.
Methods:
The last search was performed from database inception to February 28, 2022, to identify randomized and nonrandomized studies. A comprehensive search strategy was applied to Cochrane Central Register of Controlled Trials, PubMed, EMBASE, Cumulative Index to Nursing and Allied Health Literature, and ClinicalTrials.gov databases. The evidence was assessed using the Cochrane Risk of Bias Tool, the Newcastle-Ottawa scale, and GRADE. The strength of the study correlation was estimated using odds ratios, mean differences and 95 percent confidence intervals under the random-effects model. The stability of the results of this study was assessed through heterogeneity, sensitivity, subgroups, and publication bias. Statistical analysis was conducted using Review Manager (RevMan) (Version 5.4. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2020).
Results:
Five RCTs and six non-randomized controlled trials (non-RCTs) were included (n = 2,193). NPWT significantly reduced the rate of infection in colorectal incisions (odds ratio [OR], 0.57; 95% confidence interval [CI], 0.41 to 0.78; I2 = 14%), and overall wound complications (OR, 0.33; 95% CI, 0.13 to 0.88; I2 = 59%). NPWT also shortened the complete wound healing time by 3 days (mean difference, ?2.98; 95% CI, ?4.99 to ?0.97; I2 = 0%). No significant differences in the rates of wound bleeding, hematoma, length of hospital stay, readmission, reoperation, or mortality were observed. RCTs showed that the application of NPWT did not reduce the risk of SSI, and the results were consistent after sensitivity analysis. Subgroup analysis revealed that NPWT conferred greater benefits on wounds resulting from life-threatening emergency surgery and contaminated or dirty wounds. Further evidence from RCTs is warranted to ensure the effectiveness and safety of NPWT for patients undergoing colorectal surgery.
Conclusion:
NPWT is an effective intervention for the closure of wounds in patients after colorectal surgery, that significant reduction of the SSI, overall wound complications, mean complete wound healing time, and more effectively in emergency, and contaminated to dirty wounds. Treatment options should be considered in terms of cost bene?ts and adequate patient selection during shared decision-making. Further evidence is needed more randomized controlled trials to ensure the application of NPWT can effectively reduce the risk of SSI and provide the optimal treatment options for patients undergoing colorectal surgery. |
