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临床试验/NCT03885999
NCT03885999已完成不适用

Functional Anorectal Studies in Patients With Low Anterior Resection Syndrome (LARS)

Giome2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
2
主要终点
Change of Anorectal Pressure Assessed With the Fecobionics Device

研究概览

简要总结

Colorectal Cancer is the commonest cancer diagnosed for both genders combined in Hong Kong. In 2015 16.6% of all new cancer cases registered on the Hong Kong registry were cancer of colon and rectum. With recent development in oncological and surgical treatments for rectal cancer, many patients are receiving sphincter-preserving surgery with low colorectal or coloanal anastomosis to avoid permanent stoma.

Up to 80% of patients who has undergone low anterior resection (LAR), suffer from severe bowel dysfunction post operatively. Patients may suffer from a wide range of symptoms from incontinence, frequency, and urgency to constipation and feelings of incomplete emptying. This combination of symptoms after LAR is referred to as Low Anterior Resection Syndrome (LARS) which is associated with negative impact on quality of life (QoL). Originally, it was thought that these symptoms were due to early postoperative changes. Many studies report that the majority of patients experience longterm changes in quality of life after LAR. Therefore, a large number of patients worldwide are suffering from unpredictable, poor bowel function postoperatively affecting their day-to-day activity and quality of life. The cause of LARS is often multifactorial and difficult to define. Unfortunately, there is no cure for LARS at present. This trial is designed to use Fecobionics, a new Hong Kong based innovation of a simulated stool, to provide new mechanistic insights regarding anorectal physiological function post low anterior resection to understand the condition better to improve their treatment options.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Patients 18 years of age or older with history of LARS over 3 months.
  • Informed, written consent by the patient

排除标准

  • Patients who are not willing to undergo the specified tests in this study
  • Pregnant women

结局指标

主要结局

Change of Anorectal Pressure Assessed With the Fecobionics Device

时间窗: baseline and following intervention, approximately 30 seconds

The expected outcome is that the device will perform as shown in the previous human experiments (n\>60) where no adverse effects have been recorded.

次要结局

未报告次要终点

研究者

发起方
Giome
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hans Gregersen

Professor

Giome

研究点 (2)

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