Gastroenterology Department, Institut d'Investigació i Innovació Parc Taulí I3PT, Parc Taulí Hospital Universitari, Barcelona, Spain.
Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain.
Dig Endosc. 2021 Jul;33(5):797-806. doi: 10.1111/den.13860. Epub 2020 Nov 18.
There is controversy about the length of low-residue diet (LRD) for colonoscopy preparation. The aim of the study was to compare one-day vs. three-day LRD associated to standard laxative treatment for achieving an adequate colonoscopy preparation in average risk subjects with positive fecal immunochemical test undergoing screening colonoscopy.
A non-inferiority, randomized, controlled, parallel-group clinical trial was performed in the setting of average risk colorectal cancer screening program. Participants were randomized to receive 1-day vs. 3-day LRD in addition to standard polyethilenglicol treatment. Adequacy of preparation was evaluated using the Boston Bowel Preparation Scale (BBPS). Primary outcome was achieving a BBPS ≥ 2 in all colon segments. Analysis was performed for a non-inferiority margin of 5%, a 95% statistical power and one-sided 0.05 significance level.
A total of 855 patients were randomized. Adequate bowel preparation was similar between groups: 97.9% of patients in the 1-day LRD group vs 96.9% in the 3-day LRD group achieved the primary outcome (P-value for non-inferiority < 0.001). The percentage of patients with BBPS scores ≥ 8 was superior in the 1-day LRD group (254 vs 221 in the 3-day LRD group, P = 0.032). The 1-day regimen was better tolerated than the 3-day diet. 47.7% (vs 28.7%, P < 0.05) of patients rated the 1-day LRD as very easy to follow.
The 1-day LRD is non-inferior to 3-day LRD for achieving an adequate colon cleansing before average risk screening colonoscopy and it is better tolerated.
在结肠镜检查准备中，低渣饮食（LRD）的时间长短存在争议。本研究的目的是比较一天与三天 LRD 与标准泻药治疗在平均风险、粪便免疫化学检测阳性行筛查性结肠镜检查患者中达到充分结肠镜准备的效果。
在平均风险结直肠癌筛查项目中进行了一项非劣效性、随机、对照、平行组临床试验。参与者被随机分配接受 1 天或 3 天 LRD 加标准聚乙二醇治疗。使用波士顿肠道准备量表（BBPS）评估准备的充分性。主要结局是所有结肠段均达到 BBPS≥2。分析采用非劣效性边界 5%、95%统计效力和单侧 0.05 显著性水平。
共随机分配了 855 名患者。两组肠道准备充分性相似：1 天 LRD 组 97.9%的患者与 3 天 LRD 组 96.9%的患者达到主要结局（非劣效性 P 值<0.001）。1 天 LRD 组 BBPS 评分≥8 的患者比例更高（254 例比 3 天 LRD 组 221 例，P=0.032）。1 天方案比 3 天饮食更耐受。47.7%（比 28.7%，P<0.05）的患者认为 1 天 LRD 非常容易遵循。
在平均风险筛查性结肠镜检查前，1 天 LRD 与 3 天 LRD 相比非劣效，且更耐受。
