Quality of Life (QoL) and Symptom Burden After Low Rectal Resection. An Open, Effect Pilot Study With Psyllium Husk Treatment in Rectal Cancer Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- LARS score
研究概览
简要总结
Rectal cancer constitutes 1/3 of more than 4500 annually diagnosed cases of colorectal (CRC) in Norway. With the advances in radiochemotherapy, and surgical techniques, the long-term survival rate is increasing after surgery regardless of the rising incidences, with a 73% 5-year survival rate in Norway (89% for stage I-III cancer). Low anterior resection (LAR) is the most commonly performed surgical procedure with curative intent with over 500 procedures per year in Norway alone. 80 % of patients subjected to LAR suffer from the LAR syndrome (LARS) which includes grades of bowel incontinence, urgency and tenesmus contributing to reduced quality of life (QoL). Suggested means of management have been advocated without preceding randomized trials. Psyllium husk has been suggested as a nutritional supplement for symptom reduction in patients suffering from LARS, but data is limited and no larger, randomized studies regarding its effect on patients with low anterior resection syndrome have been conducted. In this pilot study preceeding a placebo-controlled RCT, the investigators aim to improve documentation of a proposed management strategy. The investigators anticipate that a reduction in intestinal symptomburden will increase QoL for this large patientgroup.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Operated with low rectal resection for rectal cancer
- •LARS score >20 at 12 months or more after surgery
- •Written consent
排除标准
- •Various conditions rendering the patient unable to answer questionnaire
- •LARS score 0-20
- •Contraindications to Psyllium husk (hypersensitivity, intestinal obstruction, reduced esophageal function, rare congenital medical conditions such as sucrase-isomaltase deficiency, fructose intolerance and glucose-galactose malabsorbtion)
研究组 & 干预措施
Intervention group
Participants will recieve Psyllium husk twice daily for 8 weeks
干预措施: Psyllium husk (Dietary Supplement)
结局指标
主要结局
LARS score
时间窗: At baseline, at 4 and 8 weeks of intervention
Low anterior resection syndrome score (0-42 points) 0-20: No LARS 21-29: Minor LARS 30-42: Major LARS
次要结局
- Quality of Life (QoL)(At baseline, at 4 and 8 weeks of intervention)
研究者
Silje Stensholt Holte
Principal Ivestigator Consultant Colorectal Surgeon
Sykehuset Telemark
