PDF(Pubmed)
Abstract：
UNASSIGNED: Up to 50% of patients who undergo rectal resection suffer from various and partly severe functional problems, despite the preservation of the anal sphincter. These complaints are defined as low anterior resection syndrome (LARS). So far, there are no randomized clinical trials regarding the most effective treatment for LARS. Our aim is to evaluate whether transanal irrigation improves bowel function and quality of life in patients following low anterior resection compared to best supportive care.
UNASSIGNED: Patients who have undergone low anterior resection will be approached for this study. On patient\'s visit, complaints regarding the defecation as well as any deterioration in their overall quality of life will be assessed using questionnaires such as the Low Anterior Resection Syndromes score, Wexner score, European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) CR-29, and Measure Yourself Medical Outcome Profile tool. Few additional target questions will be also asked, such as \"Would you recommend the treatment to anybody; did you expect the improvement following the treatment; etc.\" Questionnaires and scales will be filled on follow-up visits every 3 months for 1 year.
UNASSIGNED: This multicenter, randomized controlled trial will lead to a better understanding of LARS treatment. Moreover, it will be a hypothesis-generating study and will inform areas needing future prospective studies.
UNASSIGNED: ClinicalTrials.gov, identifier (NCT05920681).
UNASSIGNED: Patients who have undergone low anterior resection will be approached for this study. On patient\'s visit, complaints regarding the defecation as well as any deterioration in their overall quality of life will be assessed using questionnaires such as the Low Anterior Resection Syndromes score, Wexner score, European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) CR-29, and Measure Yourself Medical Outcome Profile tool. Few additional target questions will be also asked, such as \"Would you recommend the treatment to anybody; did you expect the improvement following the treatment; etc.\" Questionnaires and scales will be filled on follow-up visits every 3 months for 1 year.
UNASSIGNED: This multicenter, randomized controlled trial will lead to a better understanding of LARS treatment. Moreover, it will be a hypothesis-generating study and will inform areas needing future prospective studies.
UNASSIGNED: ClinicalTrials.gov, identifier (NCT05920681).
摘要：
■接受直肠切除术的患者中有多达50％患有各种和部分严重的功能问题，尽管保存了肛门括约肌.这些主诉被定义为低位前切除综合征（LARS）。到目前为止,目前尚无关于LARS最有效治疗的随机临床试验.我们的目的是评估与最佳支持治疗相比，经肛门冲洗是否可以改善低位前切除术后患者的肠功能和生活质量。
■接受过低位前切除术的患者将进行这项研究。在病人的访问，有关排便以及其整体生活质量恶化的投诉将使用问卷进行评估，例如低前切除综合征评分，Wexner得分,欧洲癌症研究和治疗组织（EORTC）生活质量（QOL）CR-29和测量自己的医疗结果配置文件工具。很少还会提出其他目标问题，如“你会向任何人推荐治疗吗？你是否期望治疗后有所改善；等等。“问卷和量表将每3个月填写一次随访，为期1年。
■这个多中心，随机对照试验将使人们更好地理解LARS治疗.此外，这将是一项产生假设的研究，并将为需要未来前瞻性研究的领域提供信息。
■ClinicalTrials.gov,标识符(NCT05920681)。
■接受过低位前切除术的患者将进行这项研究。在病人的访问，有关排便以及其整体生活质量恶化的投诉将使用问卷进行评估，例如低前切除综合征评分，Wexner得分,欧洲癌症研究和治疗组织（EORTC）生活质量（QOL）CR-29和测量自己的医疗结果配置文件工具。很少还会提出其他目标问题，如“你会向任何人推荐治疗吗？你是否期望治疗后有所改善；等等。“问卷和量表将每3个月填写一次随访，为期1年。
■这个多中心，随机对照试验将使人们更好地理解LARS治疗.此外，这将是一项产生假设的研究，并将为需要未来前瞻性研究的领域提供信息。
■ClinicalTrials.gov,标识符(NCT05920681)。
