Randomized Clinical Trial Assessing the Effect of Transanal Irrigation With Cone Catheter Versus Conservative Bowel Management on Symptoms of Low Anterior Resection Syndrome After Rectal Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- LARS Score
研究概览
简要总结
Objective The primary objective is to demonstrate superiority of the Peristeen cone catheter compared to standard of care.
The secondary objective is to investigate quality of life and different benefits and aspects of treatment and satisfaction with the Peristeen cone catheter.
Design of the investigation This is a randomised, open-label, parallel investigation comparing the Peristeen cone catheter with standard of care in subjects with major LARS (LARS score ≥ 30). Each subject will be enrolled for a study duration of 12 weeks. Subjects will be randomized to the treatments stratified by neo-adjuvant radiotherapy.
The comparator in this study will be current standard of care for patients with LARS which is conservative bowel management. This is defined as: Supportive therapy according to the individual treatment protocols available at each participating site.
Primary endpoint and secondary endpoints
Primary endpoint:
• LARS score, obtained from the LARS score questionnaire*
Secondary endpoints:
- Number of subjects with Major LARS*
- FIQL Score - scale 1, Modified American Society for Colorectal Surgeons Questionnaire*
- FIQL Score - scale 2, Modified American Society for Colorectal Surgeons Questionnaire*
- FIQL Score - scale 3, Modified American Society for Colorectal Surgeons Questionnaire*
- FIQL Score - scale 4, Modified American Society for Colorectal Surgeons Questionnaire*
- EQ-5D-5L - utility score*
- EQ-5D-5L - VAS score (scale 0-10 cm)*
- Satisfaction with treatment (scale 0-10 cm)*
- Number of adverse events* *All endpoints are measured per subject at study completion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 18 years of age and have full legal Capacity
- •Have given written informed consent
- •Be mental and physical capable to perform transanal irrigation with cone catheter
- •Have a LARS score ≥ 30 after rectal resection
- •Be treated according to individual treatment protocol for conservatory bowel management at participating site
- •Have proof of complete healing of the anastomosis by endoscopy or radiology before stoma closure
- •At least 3-months from last surgery in colorectum
- •Be evaluated to be suitable for transanal Irrigation procedure with a cone catheter by endoscopy, defecography or comparable procedure
排除标准
- •Active/recurrent colorectal cancer
- •Leaking anastomosis
- •Known anal or colorectal stenosis
- •Within 4 weeks of endoscopic polypectomy
- •Ischaemic colitis
- •Acute inflammatory bowel disease
- •Acute diverticulitis
- •Current or planned pregnancy
结局指标
主要结局
LARS Score
时间窗: Total score measured per subject at study completion after 12 weeks
Obtained from the LARS score questionnaire on a scale from 0-42 in total score. Subscores are summed to get the total score. With 0 indicating lowest score and 42 highest score. 0-20 indicate No LARS, 21-29 minor LARS, 30-42 Major LARS.
次要结局
- FIQL Score - Scale 1 Lifestyle, Modified American Society for Colorectal Surgeons Questionnaire(12 weeks)
- EQ-5D-5L - VAS Score(12 weeks)
- EQ-5D-5L - Utility Score(12 weeks)
- Number of Subjects With Major LARS(12 weeks)
- FIQL Score - Scale 2 Coping/Behavior, Modified American Society for Colorectal Surgeons Questionnaire(12 weeks)
- FIQL Score - Scale 3 Depression/Self-perception, Modified American Society for Colorectal Surgeons Questionnaire(12 weeks)
- FIQL Score - Scale 4 Embarrassment , Modified American Society For Colorectal Surgeons Questionnaire(12 weeks)
- Satisfaction With Treatment(12 weeks)