Department of Internal Medicine, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Long Beach Gastroenterology Associates, Long Beach, California, USA.
Clin Transl Gastroenterol. 2023 May 1;14(5):e00571. doi: 10.14309/ctg.0000000000000571.
While high-resolution manometry (HRM) is widely accepted as a safe procedure, no study has assessed the safety profile of HRM in clinical practice. This study aimed to determine the safety and tolerability of HRM and to investigate potential determinants of intolerability.
We obtained HRM procedure reports, demographics, and clinical data (2005-2022) at a tertiary center using electronic chart review. Our primary outcome was HRM tolerability. Multivariable regression was performed to identify associations between the outcome and covariates including age, sex, race, and comorbidities.
A total of 5,107 patients (60.3% female) were included. Of them, 5,050 patients (98.9%) tolerated HRM well and 57 patients (1.1%) did not. Age had a statistically significant effect on tolerance: those younger than 18 years had more than a 5-fold increase in not tolerating HRM compared with those aged 18-79 years (5.77% vs 0.99%; odds ratio [OR] = 5.44, 95% confidence interval [CI] 1.60-18.45; P = 0.007), and those aged 80 years or older were also more likely to terminate HRM (2.43% vs 0.99%; OR = 2.56, 95% CI 1.13-5.76; P = 0.024). While prior foregut surgery had a significant effect on tolerance (OR = 8.06, 95% CI 2.29-28.39; P = 0.001), other factors of race, sex, body mass index, and psychological or cognitive disorders had no significant impact. No serious complications were identified.
HRM is safe and well-tolerated with approximately 1 in every 100 patients being unable to tolerate HRM. Intolerance was more commonly seen in children and seniors due to minor symptoms of discomfort without serious complications. These data points are crucial to counsel patients in whom HRM is being considered.
尽管高分辨率测压(HRM)被广泛认为是一种安全的程序,但尚无研究评估 HRM 在临床实践中的安全性概况。本研究旨在确定 HRM 的安全性和耐受性,并探讨不耐受的潜在决定因素。
我们使用电子病历回顾,在一家三级中心获得了 2005 年至 2022 年期间的 HRM 程序报告、人口统计学和临床数据。我们的主要结局是 HRM 的耐受性。多变量回归用于确定结局与年龄、性别、种族和合并症等协变量之间的关联。
共纳入 5107 例患者(60.3%为女性)。其中,5050 例(98.9%)患者很好地耐受了 HRM,57 例(1.1%)患者不耐受。年龄对耐受性有统计学显著影响:年龄小于 18 岁的患者与 18-79 岁的患者相比,不耐受 HRM 的可能性增加了 5 倍以上(5.77% vs 0.99%;优势比[OR] = 5.44,95%置信区间[CI] 1.60-18.45;P = 0.007),而 80 岁或以上的患者也更有可能终止 HRM(2.43% vs 0.99%;OR = 2.56,95%CI 1.13-5.76;P = 0.024)。虽然先前的前肠手术对耐受性有显著影响(OR = 8.06,95%CI 2.29-28.39;P = 0.001),但种族、性别、体重指数和心理或认知障碍等其他因素对耐受性没有显著影响。未发现严重并发症。
HRM 是安全且耐受性良好的,大约每 100 例患者中就有 1 例无法耐受 HRM。由于没有严重并发症,儿童和老年人因不适症状轻微而更常出现不耐受。这些数据对于考虑 HRM 的患者的咨询至关重要。