Shah Eric D, Pelletier Elizabeth A, Greeley Carol, Sieglinger Emily E, Sanchez Jamie D, Northam Kayla A, Perrone Jessica A, Curley Michael A, Navas Christopher M, Ostler Tracy L, Burnett Greeley Aimee R, Martinez-Camblor Pablo, Baker Jason R, Chey William D
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):1070-1081. doi: 10.1016/j.cgh.2022.05.014. Epub 2022 May 29.
BACKGROUND & AIMS: We performed a clinical trial that aimed to inform the clinical utility of anorectal manometry (ARM) and balloon expulsion time (BET) as up-front tests to predict outcomes with community-based pelvic floor physical therapy as the next best step to address chronic constipation after failing an empiric trial of soluble fiber supplementation or osmotic laxatives.
We enrolled 60 treatment-naïve patients with Rome IV functional constipation failing 2 weeks of soluble fiber supplementation or osmotic laxatives. All patients underwent ARM/BET (London protocol) followed by community-based pelvic floor physical therapy. Outcomes were assessed at baseline and 12 weeks. The primary end point was clinical response (Patient Assessment of Constipation-Symptoms instrument).
Fifty-three patients completed pelvic rehabilitation and the post-treatment questionnaire. Contemporary frameworks define dyssynergia on balloon expulsion time and dyssynergic patterns (ARM), but these parameters did not inform clinical outcomes (area under the curve [AUC], <0.6). Squeeze pressure (>192.5 mm Hg on at least 1 of 3 attempts; sensitivity, 47.6%; specificity, 83.9%) and limited squeeze duration (inability to sustain 50% of squeeze pressure for >20 seconds; sensitivity, 71.4%; specificity, 58.1%) were the strongest predictors of clinical outcomes. Combining BET with squeeze duration (BET greater than 6.5 seconds and limited squeeze duration) improved predictive accuracy (AUC, 0.75; 95% CI, 0.59-0.90). BET poorly predicted outcomes as a single test (AUC, 0.54; 95% CI, 0.38-0.69).
Using ARM to evaluate squeeze profiles, rather than dyssynergia, appears useful to screen patients with chronic constipation for up-front pelvic floor physical therapy based on likelihood of response. BET appears noninformative as a single screening test (ClinicalTrials.gov: NCT04159350).
我们开展了一项临床试验，旨在评估肛门直肠测压法（ARM）和气球排出时间（BET）作为初始检查的临床实用性，以预测在经验性试用可溶性纤维补充剂或渗透性泻药失败后，以社区为基础的盆底物理治疗作为解决慢性便秘的下一步最佳措施的效果。
我们招募了60例初治的符合罗马IV功能性便秘标准且已试用2周可溶性纤维补充剂或渗透性泻药失败的患者。所有患者均接受ARM/BET检查（伦敦方案），随后接受以社区为基础的盆底物理治疗。在基线和12周时评估结果。主要终点是临床反应（便秘症状患者评估工具）。
53例患者完成了盆底康复和治疗后问卷调查。当代框架根据气球排出时间和不协调模式（ARM）定义排便协同失调，但这些参数并不能预测临床结果（曲线下面积[AUC]，<0.6）。挤压压力（3次尝试中至少1次>192.5 mmHg；敏感性，47.6%；特异性，83.9%）和挤压持续时间有限（无法维持50%的挤压压力超过20秒；敏感性，71.4%；特异性，58.1%）是临床结果的最强预测因素。将BET与挤压持续时间相结合（BET大于6.5秒且挤压持续时间有限）可提高预测准确性（AUC，0.75；95%CI，0.59 - 0.90）。单独使用BET预测结果较差（AUC，0.54；95%CI，0.38 - 0.69）。
使用ARM评估挤压情况，而非排便协同失调，似乎有助于根据反应可能性对慢性便秘患者进行筛查，以便进行初始盆底物理治疗。单独使用BET作为筛查测试似乎并无参考价值（ClinicalTrials.gov：NCT04159350）。
