van Hooft Jeanin E, Bemelman Willem A, Breumelhof Ronald, Siersema Peter D, Kruyt Philip M, van der Linde Klaas, Veenendaal Roeland A, Verhulst Marie-Louise, Marinelli Andreas W, Gerritsen Josephus J G M, van Berkel Anne-Marie, Timmer Robin, Grubben Marina J A L, Scholten Pieter, Geraedts Alfons A M, Oldenburg Bas, Sprangers Mirjam A G, Bossuyt Patrick M M, Fockens Paul
Department of Gastroenterology, Academic Medical Center, Amsterdam, The Netherlands.
BMC Surg. 2007 Jul 3;7:12. doi: 10.1186/1471-2482-7-12.
Acute left-sided colonic obstruction is most often caused by malignancy and the surgical treatment is associated with a high mortality and morbidity rate. Moreover, these operated patients end up with a temporary or permanent stoma. Initial insertion of an enteral stent to decompress the obstructed colon, allowing for surgery to be performed electively, is gaining popularity. In uncontrolled studies stent placement before elective surgery has been suggested to decrease mortality, morbidity and number of colostomies. However stent perforation can lead to peritoneal tumor spill, changing a potentially curable disease in an incurable one. Therefore it is of paramount importance to compare the outcomes of colonic stenting followed by elective surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in a randomized multicenter fashion.
METHODS/DESIGN: Patients with acute left-sided malignant colonic obstruction eligible for this study will be randomized to either emergency surgery (current standard treatment) or colonic stenting as bridge to elective surgery. Outcome measurements are effectiveness and costs of both strategies. Effectiveness will be evaluated in terms of quality of life, morbidity and mortality. Quality of life will be measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQ-VAS). Morbidity is defined as every event leading to hospital admission or prolonging hospital stay. Mortality will be analyzed as total mortality as well as procedure-related mortality. The total costs of treatment will be evaluated by counting volumes and calculating unit prices. Including 120 patients on a 1:1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. Differences in quality of life and morbidity will be analyzed using mixed-models repeated measures analysis of variance. Mortality will be compared using Kaplan-Meier curves and log-rank statistics.
The Stent-in 2 study is a randomized controlled multicenter trial that will provide evidence whether or not colonic stenting as bridge to surgery is to be performed in patients with acute left-sided colonic obstruction.
Current Controlled Trials ISRCTN46462267.
急性左侧结肠梗阻最常见的病因是恶性肿瘤，手术治疗的死亡率和发病率较高。此外，这些接受手术的患者最终会留有临时或永久性造口。最初插入肠内支架以解除梗阻的结肠，使手术能够择期进行，这种方法越来越受欢迎。在非对照研究中，有人提出在择期手术前放置支架可降低死亡率、发病率和结肠造口的数量。然而，支架穿孔可导致腹膜肿瘤播散，使潜在可治愈的疾病变为不可治愈。因此，以随机多中心方式比较结肠支架置入后择期手术与急诊手术治疗急性左侧恶性结肠梗阻的疗效至关重要。
方法/设计：符合本研究条件的急性左侧恶性结肠梗阻患者将被随机分为急诊手术组（现行标准治疗）或结肠支架置入组作为择期手术的桥梁。观察指标为两种治疗策略的有效性和成本。有效性将根据生活质量、发病率和死亡率进行评估。生活质量将用标准化问卷（欧洲癌症研究与治疗组织核心问卷QLQ-C30、欧洲癌症研究与治疗组织结直肠癌特异性问卷QLQ-CR38、EQ-5D和EQ-VAS）进行测量。发病率定义为导致住院或延长住院时间的每一个事件。死亡率将分析总死亡率以及与手术相关的死亡率。治疗的总成本将通过计算数量和计算单价来评估。以1:1的比例纳入120例患者，使用双侧显著性水平为0.05的两组t检验，将有80%的把握度检测欧洲癌症研究与治疗组织核心问卷QLQ-C30全球健康量表上0.5的效应量。生活质量和发病率的差异将使用混合模型重复测量方差分析进行分析。死亡率将使用Kaplan-Meier曲线和对数秩统计进行比较。
Stent-in 2研究是一项随机对照多中心试验，将提供证据证明急性左侧结肠梗阻患者是否应进行结肠支架置入作为手术的桥梁。
当前受控试验ISRCTN46462267。
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