A Randomized Controlled Clinical Trial of Transanal Irrigation Versus Conservative Treatment in Patients With Low Anterior Resection Syndrome After Rectal Cancer Surgery
A Randomized Controlled Clinical Trial of Transanal Irrigation Versus Conservative Treatment in Patients With Low Anterior Resection Syndrome After Rectal Cancer Surgery
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DOI：
10.1097/sla.0000000000005482
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发表时间：
2023-01-01
影响因子：
9
通讯作者：
Abraham-Nordling, Mirna
中科院分区：
文献类型：
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作者：
Pieniowski, Emil H. A.;Bergstroem, Charlotta M.;Abraham-Nordling, Mirna
目的：本研究旨在评价经肛门冲洗（TAI）作为低位前切除术综合征（LARS）的治疗方法。背景：LARS是直肠癌保肛手术后常见的肠道疾病。尽管对LARS进行了对症治疗，但许多患者仍会出现肠道症状，可能对生活质量（QoL）产生负面影响。TAI是一种治疗策略，其临床经验是有希望的，但科学证据有限。材料与方法：采用多中心随机对照研究方法，对TAI（介入）与保守治疗（对照）进行比较。入选标准为主要LARS，年龄超过18岁，低位前切除吻合术和功能障碍性造口作为初次手术，造口逆转后>6个月，吻合术无渗漏或狭窄迹象，1年随访时无复发迹象。主要终点是12个月随访时通过LARS评分、克利夫兰诊所佛罗里达粪便失禁评分和4个研究特定问题测量的肠功能差异。次要结局为QoL。结果：共纳入45例患者，TAI组22例，对照组23例。分别有16例和22例患者接受了随访。在12个月时，TAI组患者报告的LARS评分（22.9 vs 32.4; P=0.002）和克利夫兰诊所佛罗里达粪便失禁评分（6.4 vs 9.2; P=0.050）显著较低。此外，TAI组患者的QoL评分也显著高于对照组[16个欧洲癌症研究与治疗组织生活质量问卷核心30（EORTC QLQ-C30）QoL方面中的8个]。结论：结果证实了我们的临床经验，TAI减少了LARS中的症状，改善了QoL。
Objective:The aim of the study was to evaluate transanal irrigation (TAI) as a treatment for low anterior resection syndrome (LARS). Background:LARS is a bowel disorder that is common after sphincter preserving rectal cancer surgery. Despite symptomatic medical treatment of LARS many patients still experience bowel symptoms that may have a negative impact on quality of life (QoL). TAI is a treatment strategy, of which the clinical experience is promising but scientific evidence is limited. Materials and Methods:A multicenter randomized trial comparing TAI (intervention) with conservative treatment (control) was performed. Inclusion criteria were major LARS, age above 18 years, low anterior resection with anastomosis and a defunctioning stoma as primary surgery, >6 months since stoma reversal, anastomosis without signs of leakage or stricture, and no signs of recurrence at 1-year follow-up. The primary endpoint was differences in bowel function at 12-month follow-up measured by LARS score, Cleveland Clinic Florida Fecal Incontinence Score, and 4 study-specific questions. The secondary outcome was QoL. Results:A total of 45 patients were included, 22 in the TAI group and 23 in the control group. Follow-up was available for 16 and 22 patients, respectively. At 12 months, patients in the TAI group reported significantly lower LARS scores (22.9 vs 32.4; P=0.002) and Cleveland Clinic Florida Fecal Incontinence Score (6.4 vs 9.2; P=0.050). In addition, patients in the TAI group also scored significantly higher QoL [8 of 16 European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) QoL aspects] compared with the control group. Conclusions:The results confirm our clinical experience that TAI reduces symptoms included in LARS and improves QoL.