A randomized trial comparing transanal irrigation and percutaneous tibial nerve stimulation in the management of low anterior resection syndrome
A randomized trial comparing transanal irrigation and percutaneous tibial nerve stimulation in the management of low anterior resection syndrome
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DOI：
10.1111/codi.14870
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发表时间：
2019-10-21
影响因子：
3.4
通讯作者：
Placer-Galan, C.
中科院分区：
文献类型：
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作者：
Enriquez-Navascues, J. M.;Labaka-Arteaga, I;Placer-Galan, C.
目的比较经肛冲洗（TAI）与胫后神经刺激（PTNS）治疗重度和慢性下前切除术综合征（LARS）的疗效。方法在某大学附属医院进行两组平行、开放标签随机对照试验。研究人群包括LARS评分在29分以上且在1年前接受直肠手术的患者。这些患者采用中央随机化系统，按照1:1的顺序随机分配到TAI或PTNS。主要研究结果是在每次干预中至少50%的患者中至少降低一个LARS级别。结果共纳入27例患者，其中TAI = 13例，PTNS = 14例。两组的混杂因素相似。4例患者因合并疾病或早期辍学而被排除，留下23例（TAI, n = 10； PTNS, n = 13）进行分析。10名患者中有8名和13名患者中有4名分别被降级为TAI和PTNS。TAI组的LARS中位评分从35[四分位间距（IQR） 32-39]降至12 (IQR 12-26) (P = 0.021)， PTNS组从35 （IQR 34-37）降至30 (IQR 25-33) （P = 0.045）。TAI和PTNS的Vaizey评分分别从15分（IQR 11-18）降至6分（IQR 4-7） （P = 0.037），从14分（IQR 13-17）降至9分（IQR 7-10） （P = 0.007），分别有80%和38%的患者下降幅度均在50%以上。两组患者的生活质量均有改善。结论两种治疗均改善了LARS评分，但仅在TAI组有显著性差异。
Aim To assess the effectiveness of transanal irrigation (TAI) compared with posterior tibial nerve stimulation (PTNS) in severe and chronic low anterior resection syndrome (LARS). Method A two-group parallel, open-label randomized controlled trial carried out in a single university hospital. The study population included patients with a LARS scale score of more than 29 points who had undergone rectal surgery more than 1 year previously. These were randomly allocated, with a central randomization system, following a 1:1 sequence to TAI or PTNS. The main study outcome was to achieve a reduction of at least one LARS grade in at least 50% of the patients, for each intervention. Results A total of 27 patients (TAI = 13, PTNS = 14) were randomized. Both groups were similar with regard to confounding factors. Four patients were excluded because of intercurrent disease or early dropout, leaving 23 (TAI, n = 10; PTNS, n = 13) for analysis. Eight out of 10 and 4 out of 13 patients were downgraded with TAI and PTNS, respectively. The median LARS score decreased from 35 [interquartile range (IQR) 32-39] to 12 (IQR 12-26) (P = 0.021) for the TAI group and from 35 (IQR 34-37) to 30 (IQR 25-33) (P = 0.045) for the PTNS group. The Vaizey score fell from 15 (IQR 11-18) to 6 (IQR 4-7) (P = 0.037) and from 14 (IQR 13-17) to 9 (IQR 7-10) (P = 0.007) with TAI and PTNS, respectively, with 80% and 38% of patients, respectively, showing decreases of more than 50%. Improvement in quality of life was observed in both groups. Conclusion Both treatments improved the LARS score in this study but this was only significant in the TAI group.