Gimeno-García Antonio Z, Hernández Goretti, Baute Dorta José Luis, Reygosa Cristina, de la Barreda Raquel, Hernandez-Bustabad Alberto, Amaral Carla, Cedrés Yaiza, Del Castillo Rocío, Nicolás-Pérez David, Jiménez Alejandro, Alarcon-Fernández Onofre, Hernandez-Guerra Manuel, Romero Rafael, Alonso Inmaculada, González Yanira, Adrian Zaida, Hernandez Domingo, Ramos Laura, Carrillo Marta, Felipe Vanessa, Hernández Anjara, Rodríguez-Jiménez Consuelo, Quintero Enrique
Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB), La Laguna, Spain.
Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, Spain.
Front Med (Lausanne). 2021 Mar 22;8:654847. doi: 10.3389/fmed.2021.654847. eCollection 2021.
We tested the hypothesis that an enhanced bowel preparation strategy (EBS) improves colonic cleansing in patients at high risk for inadequate bowel cleansing (HRI). This prospective randomized clinical trial included consecutive HRI patients referred for outpatient colonoscopy between February and October 2019. HRI was considered if patients scored >1.225 according to a previously validated bowel-cleansing predictive score. HRI patients were randomized (1:1) to a low-volume conventional bowel cleansing strategy (CBS) (1-day low residue diet (LRD) plus 2 L of polyethylene glycol (PEG) plus ascorbic acid) or to an EBS (3-day LRD plus 10 mg oral bisacodyl plus 4 L PEG). The Boston Bowel Preparation Scale (BBPS) was used to assess the quality of cleanliness. Intention-to-treat (ITT) and per protocol (PP) analyses were performed. A sample size of 130 patients per group was estimated to reach a 15% difference in favor of EBP. A total of 253 HRI patients were included (mean age 69.8 ± 9.5 years, 51.8% women). No statistically significant differences were found in the BBPS scale between the two groups in the ITT analysis (CBS 76.8% vs. EBS 79.7%, = 0.58) or PP analysis (CBS 78% vs. EBS 84.3%, = 0.21), risk difference 2.9% (95% CI-7.26 to 39.16) in the ITT analysis, or risk difference 6.3% (95% CI-3.48 to 16.08) in PP analysis. No differences in preparation tolerance, compliance, adverse effects, or colonoscopy findings were found. EBS is not superior to CBS in hard-to-prepare patients. (EUDRACT: 2017-000787-15, NCT03830489). www.ClinicalTrials.gov, identifier NCT03830489.
强化肠道准备策略（EBS）可改善肠道清洁不佳高风险（HRI）患者的结肠清洁效果。这项前瞻性随机临床试验纳入了2019年2月至10月期间因门诊结肠镜检查而转诊的连续HRI患者。如果患者根据先前验证的肠道清洁预测评分得分>1.225，则判定为HRI。HRI患者被随机（1:1）分为低容量传统肠道清洁策略（CBS）组（1天低渣饮食（LRD）加2升聚乙二醇（PEG）加抗坏血酸）或EBS组（3天LRD加10毫克口服比沙可啶加4升PEG）。采用波士顿肠道准备量表（BBPS）评估清洁质量。进行了意向性分析（ITT）和符合方案分析（PP）。估计每组130例患者的样本量可得出有利于EBP的15%的差异。总共纳入了253例HRI患者（平均年龄69.8±9.5岁，51.8%为女性）。在ITT分析（CBS组76.8% vs. EBS组79.7%，P = 0.58）或PP分析（CBS组78% vs. EBS组84.3%，P = 0.21）中，两组在BBPS量表上未发现统计学显著差异，ITT分析中的风险差异为2.9%（95%CI -7.26至39.16），PP分析中的风险差异为6.3%（95%CI -3.48至16.08）。在准备耐受性、依从性、不良反应或结肠镜检查结果方面未发现差异。在难准备的患者中，EBS并不优于CBS。（欧盟临床试验注册号：2017-000787-15，美国国立医学图书馆临床试验标识符：NCT03830489）。www.ClinicalTrials.gov，标识符NCT03830489。
