Klimovskij Michail, Civilka Ignas, Aleinikov Andrej, Aukstikalnis Tomas, Christensen Peter, Dulskas Audrius
Department of Colorectal Surgery, East Sussex Healthcare Trust, Hastings, United Kingdom.
Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
Front Surg. 2024 May 13;11:1384815. doi: 10.3389/fsurg.2024.1384815. eCollection 2024.
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.
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.
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.
ClinicalTrials.gov, identifier (NCT05920681).
尽管保留了肛门括约肌，但高达50%接受直肠切除术的患者仍存在各种且部分较为严重的功能问题。这些症状被定义为低位前切除综合征（LARS）。到目前为止，尚无关于LARS最有效治疗方法的随机临床试验。我们的目的是评估与最佳支持治疗相比，经肛门冲洗是否能改善低位前切除术后患者的肠道功能和生活质量。
将邀请接受低位前切除术的患者参与本研究。在患者就诊时，将使用诸如低位前切除综合征评分、韦克斯纳评分、欧洲癌症研究与治疗组织（EORTC）生活质量（QOL）CR - 29以及自我测量医疗结果概况工具等问卷，评估患者关于排便的主诉以及其整体生活质量的任何恶化情况。还将询问一些额外的目标问题，例如“你会向任何人推荐这种治疗方法吗；你期望治疗后有所改善吗；等等”。问卷和量表将在1年的随访中每3个月填写一次。
这项多中心、随机对照试验将有助于更好地理解LARS的治疗方法。此外，它将是一项产生假设的研究，并将为未来需要进行前瞻性研究的领域提供信息。
ClinicalTrials.gov，标识符（NCT05920681）。
