2010-08-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/646219摘要：由於醫療技術發展迅速，越來越多65 歲以上老年人接受外科手術治療。外科手術特別是腸胃道手術後，常導致老年病患腸胃道功能改變、延長禁食、疼痛、制動、疲憊、認知功能下降及自我照顧功能退化，再加上原本老化所帶來的唾液分泌減少、口咽肌肉力量下降、味蕾退化、延遲性吞嚥等生理變化(Presbyphagia)，使得腸胃道手術後老年病患的口腔健康不良，對於後續營養狀況的恢復亦帶來嚴重的影響。因此，本計畫將腸胃道術後之六十五歲以上老年病患列為主要照護對象，研究將分三年以兩階段進行：階段一：前瞻、縱貫性觀察調查，藉以發展實證性口腔護理模式(2009.8-2010.12)本階段採連續取樣，以一年半時間，在120位腸胃道術後老年病患住院期間及出院後(術前、術後三、五、七天、及術後第二、八周)，以六個時間點對其口腔衛生、吞嚥反射功能、味覺的感官、整體性口腔健康與營養功能能作長期、前瞻性的觀察，藉以發展最適於老年病患使用之實證性的口腔護理模式。階段二：以隨機臨床試驗檢視口腔護理在口腔健康及營養恢復之效能(2011.1-2012.7)此階段採隨機、單盲的臨床試驗(Randomized controlled trials) ，在術前、術後三、五、七天、及術後第二、八周時，測試、比較此一口腔護理模式在改善口腔衛生狀態，維持吞嚥反射功能、味覺敏感度，整體性口腔健康，進而改善腸胃道術後之六十五歲以上老年病患營養狀態之效能。預計在基礎術前評估完成後，個案將依胃部和腸部手術之不同，分層隨機納入實驗組或臨床常規組。實驗組增加研究中制訂之口腔護理照護(含口腔清潔及口腔功能刺激)持續至出院，臨床常規組則接受病房常規口腔照護。研究之結果變項包含：口腔衛生、吞嚥反射、味覺敏感度、整體性口腔健康及營養狀態。結果變項之檢測方式包含：「牙菌斑指標」、「口腔評估指引」、「重複吞嚥動作測試」、「味覺試紙測試」、「一般口腔健康測度指數」及「迷你營養評估量表」。預計兩組收案共120~150名，研究進行為期1 年半。待完成所有個案追蹤及資料收集，將以SAS 統計軟體，根據臨床試驗規範及intention-to-treat 原則分析及報告研究結果。分析將採Generalized Estimating Equations來判別實驗組及臨床常規組在結果變項發生及改變的差異，以提出此一新型口腔護理模式在接受腸胃道手術的臺灣老年病患之實證成效，以供日後建立及推動手術後老年病患口腔健康及營養功能介入之臨床參考及政策依據。<br> Abstract: Oral health is an important contributor to the health and well-being. Recent associationsbetween oral health and systemic disease have led to renewed interest in oral health and itscontribution to health outcomes. The aim of this study is to develop and evaluate a newlydeveloped oral care protocol for the improvement of oral health and nutritional status in olderpatients who undergoing midline incision abdominal surgery during hospitalization and 8weeks post surgery.Phase I: Given the dearth of data on these outcomes of interest, a prospectiveobservational survey will be conducted to assess the prevalence and status of oral hygiene,taste sensitivity, swallowing ability, oral health, and nutritional status among older patientsduring and post hospitalization. Based on power analysis, 120 eligible older patients will beenrolled and assessed face-to-face. Findings will add to develop an up-to-date evidence-basedoral care protocol.Phase II: A prospective, single-blind, one-center randomized controlled trial (RCT)using a computer generalized randomization list with a block size of four, will be conductedto test the effects of this newly developed oral care protocol in improving oral health(measured by plaque index, edible taste strips, repetitive saliva swallowing test, oralassessment guide, and general oral health assessment) and nutritional status (measured byMNA and weight changes) in older patients from admission baseline (T0) to postoperativeDay 3 (T1), Day 5 (T2), Day 7 (T3), and 2 weeks (T4) and 8 weeks (T5) post surgery.Sample will be recruited consecutively from four surgical units, 9A, 9C, 7B, 6A, at NTUhospital with a target population of older patients aged 65 years and older who undergoingelective midline incision abdominal surgery with a postoperative length of stay over 5 days.Based on power analysis, a sample size of 120-150 is sufficient to reach 80% power ofanalysis. Stratified random assignment by the type of surgery (gastric versus colorectal) to theexperimental or the usual care group will be performed to have the most precision of theintervention effect. Strict adherence to the resulting randomization will be ensured.The intervention consisted of a daily oral care protocol on two core components, oralcleaning and oral function stimulation on top of hospital routine care. Usual care consisted ofstandard hospital services and the same physicians provide care to patients in bothexperimental and usual care groups.Data will be analyzed using the SAS statistical package version 9.1. Theintention-to-treat principle will be used. Generalized Estimating Equation (GEE) analysis willbe performed to test the intervention effect. This study will be the first to use a RCT design totest the effect of oral care in improving oral health and subsequent nutritional status in olderpatients post abdominal surgery. Since more and more older patients presenting for majorsurgery, the findings of this study will have implications in both clinical practices and policymaking in Taiwan and worldwide as well.Tumor microenvironmentMetastasisCancer associated fibroblasts (CAFs)Coordinated migration