跳至主要内容
临床试验/NCT06724198
NCT06724198已完成不适用

Quality of Life (QoL) and Symptom Burden After Low Rectal Resection. An Open, Effect Pilot Study With Psyllium Husk Treatment in Rectal Cancer Patients.

Sykehuset Telemark2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

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

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

Experimental

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

发起方
Sykehuset Telemark
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Silje Stensholt Holte

Principal Ivestigator Consultant Colorectal Surgeon

Sykehuset Telemark

研究点 (2)

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