Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
Clin Gastroenterol Hepatol. 2023 Apr;21(4):1082-1090. doi: 10.1016/j.cgh.2022.03.022. Epub 2022 Mar 24.
BACKGROUND & AIMS: Rectal evacuation disorders are common among constipated patients. We aimed to evaluate the accuracy of an investigational point-of-care test (rectal expulsion device [RED]) to predict outcomes with community-based pelvic floor physical therapy.
We enrolled patients meeting Rome IV criteria for functional constipation failing fiber/laxatives for more than 2 weeks. RED was inserted and self-inflated, and then time-to-expel was measured in a left lateral position. All patients underwent empiric community-based pelvic floor physical therapy in routine care with outcomes measured at 12 weeks. The primary end point was global clinical response (Patient Assessment of Constipation Symptoms score reduction, >0.75 vs baseline). Secondary end points included improvement in health-related quality-of-life (Patient Assessment of Constipation Quality of Life score reduction, >1.0) and complete spontaneous bowel movement frequency (Food and Drug Administration complete spontaneous bowel movement responder definition).
Thirty-nine patients enrolled in a feasibility phase to develop the use-case protocol. Sixty patients enrolled in a blinded validation phase; 52 patients (mean, 46.9 y; 94.2% women) were included in the intention-to-treat analysis. In the left lateral position, RED predicted global clinical response (generalized area under the curve [gAUC], 0.67; 95% CI, 0.58-0.76]), health-related quality-of-life response (gAUC, 0.67; 95% CI, 0.58-0.77; P < .001), and complete spontaneous bowel movement response (gAUC, 0.63; 95% CI, 0.57-0.71; P < .001). As a screening test, a normal RED effectively rules out evacuation disorders (expected clinical response, 8.9%; P = .042). Abnormal RED in the left lateral position (defined as expulsion within 5 seconds or >120 seconds) predicted 48.9% clinical response to physical therapy. A seated maneuver enhanced the likelihood of clinical response (71.1% response with seated RED retained >13 seconds) but likely is unnecessary in most settings.
RED offers an opportunity to disrupt the paradigm by offering a personalized approach to managing chronic constipation in the community (Clinicaltrials.gov: NCT04159350).
直肠排空障碍在便秘患者中很常见。我们旨在评估一种新的即时护理检测手段（直肠排空装置[RED]）预测基于社区的盆底物理治疗结局的准确性。
我们招募了符合罗马 IV 功能性便秘标准且纤维/泻药治疗超过 2 周失败的患者。RED 被插入并自行充气，然后在左侧卧位时测量排空时间。所有患者在常规护理中接受经验性的基于社区的盆底物理治疗，并在 12 周时测量结局。主要终点是总体临床反应（患者便秘症状评分降低，>0.75 分比基线）。次要终点包括改善健康相关生活质量（患者便秘生活质量评分降低，>1.0 分）和完全自发排便频率（美国食品和药物管理局完全自发排便应答定义）。
39 例患者入组参与开发使用案例方案的可行性阶段。60 例患者入组盲法验证阶段；52 例患者（平均年龄 46.9 岁；94.2%为女性）被纳入意向治疗分析。在左侧卧位时，RED 预测总体临床反应（广义曲线下面积[gAUC]，0.67；95%CI，0.58-0.76]）、健康相关生活质量反应（gAUC，0.67；95%CI，0.58-0.77；P<.001）和完全自发排便反应（gAUC，0.63；95%CI，0.57-0.71；P<.001）。作为一种筛查试验，正常的 RED 可有效排除排空障碍（预期临床反应率，8.9%；P=.042）。左侧卧位时 RED 异常（定义为 5 秒内或>120 秒排空）预测物理治疗的临床反应率为 48.9%。坐姿动作提高了临床反应的可能性（71.1%的反应中坐姿 RED 保持>13 秒），但在大多数情况下可能没有必要。
RED 为通过提供一种个性化的方法来管理社区中的慢性便秘提供了一个机会，从而打破传统观念（Clinicaltrials.gov：NCT04159350）。
