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Identification of Clinical Outcome Measures for Recovery of Gastrointestinal Motility in Postoperative Ileus

机译:术后肠梗阻恢复胃肠动力的临床结果措施的鉴定

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Objective: To identify clinical hallmarks associated with recovery of gastrointestinal transit.Background: Impaired gastrointestinal transit or postoperative ileus largely determines clinical recovery after abdominal surgery. However, validated clinical hallmarks of gastrointestinal recpvery to evaluate new treatments and readiness for discharge from the hospital are lacking. Methods: Gastric emptying and colonic transit were scintigraphically assessed from postoperative day 1 to 3 in 84 patients requiring elective colonic surgery and were compared with clinical parameters. The clinical hallmark that best reflected recovery of gastrointestinal transit was validated using data from a multicenter trial of 320 segmental colectomy patients. Results: Seven of 84 patients developed a major complication with paralytic ileus characterized by total inhibition of gastrointestinal motility and were excluded from further analysis. In the remaining patients, recovery of colonic transit (defined as geometric center of radioactivity >2 on day 3), but not gastric emptying, was significantly correlated with clinical recovery (p = -0.59, P < 0.001). Conversely, the combined outcome measure of tolerance of solid food and having had defecation (SF + D) (area under the curve = 0.9, SE = 0.04, 95% CI = 0.79-0.95, P < 0.001), but not time to first flatus, best indicated recovery of gastrointestinal transit with a positive predictive value of 93% (95% CI = 78-99). Also in the main clinical trial, multiple regression analysis revealed that SF + D best predicted the duration of hospital stay. Conclusions: Our data indicate that the time to SF + D best reflects recovery of gastrointestinal transit and therefore should be considered as primary outcome measure in future clinical trials on postoperative ileus.(Netherlands National Trial Register, number NTR1884 and NTR222)
机译:目的:确定与胃肠道运输恢复相关的临床标志。背景:胃肠道运输受损或术后肠梗阻在很大程度上决定了腹部手术后的临床恢复。但是,缺乏评估胃肠道反应的临床特征来评估新的治疗方法和出院准备情况。方法:对84例需要行结肠癌手术的患者,从术后第1天到第3天进行闪烁显像,评估其胃排空和结肠转运情况,并与临床参数进行比较。使用来自320例部分结肠切除术患者的多中心试验的数据验证了能最好地反映胃肠道运输恢复的临床标志。结果:84例患者中有7例患有严重的麻痹性肠梗阻并发症,其特征是完全抑制了肠胃蠕动,因此被排除在进一步分析之外。在其余患者中,结肠转运的恢复(定义为第3天放射性几何中心> 2)而不是胃排空与临床恢复显着相关(p = -0.59,P <0.001)。相反,对固体食物的耐受性和排便(SF + D)的综合结果量度(曲线下的面积= 0.9,SE = 0.04,95%CI = 0.79-0.95,P <0.001),但不是第一次肠胃气,最能说明胃肠道运输恢复,阳性预测值为93%(95%CI = 78-99)。同样在主要临床试验中,多元回归分析表明,SF + D可以最好地预测住院时间。结论:我们的数据表明,达到SF + D的时间最能反映胃肠道的恢复,因此在以后的肠梗阻临床试验中应将其视为主要的结局指标。(荷兰国家试验注册号NTR1884和NTR222)

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