Abstract：
BACKGROUND: Continence issues due to organic causes including previous colorectal surgery or neurological issues might benefit from Transanal irrigation (TAI) that proved to be highly effective but with a number of limitations including a relatively high discontinuation rates. Our study was aimed at evaluating the efficacy of an advanced protocol tailored to each patient to prevent dropout and increase satisfaction, independence, and quality of life.
METHODS: This was a prospective, interventional, multicenter, nonrandomized study involving children aged 4-18 years with bowel dysfunction unresponsive to conventional treatments who required TAI. TAI was performed in accordance to the best standards of care with a total irrigation volume that was determined based on low emission X-Ray barium enemas performed at the very beginning of the study. All patients underwent training and assessments of continence, patients\' perspectives and quality of life were performed at different timepoints from enrollment (T0) up to 6 months since TAI was introduced (T3).
RESULTS: A total of 78 patients were enrolled. Male to female ratio was 1.4:1. Mean age at enrollment was 106.1 ± 42.8 months. Discontinuation was reported by 3 patients (3.8 %). Continence, satisfaction and a number of other outcome measures increased from baseline (T0) to the last visit (T3). In particular, mean Rintala total score increased linearly from 7.8 to 14.8 during the study period (T0 to T3 timepoints). On a multivariate analysis, the only parameter that proved to be inversely associated with continence as well as with other outcome measures was the use of laxatives at enrollment and during the study.
CONCLUSIONS: This study has demonstrated the high efficacy of this innovative patient-tailored TAI protocol across all assessed scores. Of note, given the negative impact of laxatives, our findings suggest limiting their use in this patient population to further increase the efficacy of the procedure.
METHODS: This was a prospective, interventional, multicenter, nonrandomized study involving children aged 4-18 years with bowel dysfunction unresponsive to conventional treatments who required TAI. TAI was performed in accordance to the best standards of care with a total irrigation volume that was determined based on low emission X-Ray barium enemas performed at the very beginning of the study. All patients underwent training and assessments of continence, patients\' perspectives and quality of life were performed at different timepoints from enrollment (T0) up to 6 months since TAI was introduced (T3).
RESULTS: A total of 78 patients were enrolled. Male to female ratio was 1.4:1. Mean age at enrollment was 106.1 ± 42.8 months. Discontinuation was reported by 3 patients (3.8 %). Continence, satisfaction and a number of other outcome measures increased from baseline (T0) to the last visit (T3). In particular, mean Rintala total score increased linearly from 7.8 to 14.8 during the study period (T0 to T3 timepoints). On a multivariate analysis, the only parameter that proved to be inversely associated with continence as well as with other outcome measures was the use of laxatives at enrollment and during the study.
CONCLUSIONS: This study has demonstrated the high efficacy of this innovative patient-tailored TAI protocol across all assessed scores. Of note, given the negative impact of laxatives, our findings suggest limiting their use in this patient population to further increase the efficacy of the procedure.
摘要：
背景：由于器质性原因引起的连续性问题，包括以前的结直肠手术或神经系统问题，可能会受益于经肛门冲洗（TAI），该冲洗被证明是非常有效的，但存在许多局限性，包括相对较高的停药率。我们的研究旨在评估针对每位患者量身定制的高级方案的有效性，以防止患者退出并提高满意度。独立性,和生活质量。
方法：这是一个前瞻性的，介入,多中心，非随机研究纳入4-18岁肠功能障碍儿童，对需要TAI的常规治疗无反应。TAI是根据最佳护理标准进行的，总冲洗量是根据研究开始时进行的低发射X射线钡灌肠确定的。所有患者都接受了节制训练和评估，我们在纳入研究后的不同时间点(T0)对患者的观点和生活质量进行了评估,直至TAI引入后6个月(T3).
结果：共纳入78例患者。男女比例为1.4:1。入组时的平均年龄为106.1±42.8个月。3例患者报告停药（3.8%）。继续,满意度和其他一些结局指标从基线(T0)到最后一次访视(T3)增加.特别是,在研究期间(T0至T3时间点),平均Rintala总分从7.8线性增加至14.8.在多变量分析中，唯一被证明与尿失禁以及其他结局指标呈负相关的参数是纳入时和研究期间使用泻药.
结论：这项研究证明了这种创新的患者定制TAI方案在所有评估评分中的高疗效。值得注意的是，考虑到泻药的负面影响，我们的研究结果表明,限制其在该患者人群中的使用,以进一步提高该手术的疗效.
方法：这是一个前瞻性的，介入,多中心，非随机研究纳入4-18岁肠功能障碍儿童，对需要TAI的常规治疗无反应。TAI是根据最佳护理标准进行的，总冲洗量是根据研究开始时进行的低发射X射线钡灌肠确定的。所有患者都接受了节制训练和评估，我们在纳入研究后的不同时间点(T0)对患者的观点和生活质量进行了评估,直至TAI引入后6个月(T3).
结果：共纳入78例患者。男女比例为1.4:1。入组时的平均年龄为106.1±42.8个月。3例患者报告停药（3.8%）。继续,满意度和其他一些结局指标从基线(T0)到最后一次访视(T3)增加.特别是,在研究期间(T0至T3时间点),平均Rintala总分从7.8线性增加至14.8.在多变量分析中，唯一被证明与尿失禁以及其他结局指标呈负相关的参数是纳入时和研究期间使用泻药.
结论：这项研究证明了这种创新的患者定制TAI方案在所有评估评分中的高疗效。值得注意的是，考虑到泻药的负面影响，我们的研究结果表明,限制其在该患者人群中的使用,以进一步提高该手术的疗效.
