NCT06923150招募中不适用
A Randomised Clinical Investigation to Assess Efficacy of Low Volume Transanal Irrigation by Qufora® IrriSedo MiniGo Versus Conservative Treatment for Low Anterior Resection Syndrome Patients
Qufora A/S9 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年6月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 9
- 主要终点
- LARS score difference
研究概览
简要总结
The purpose of this post-market clinical follow up study is to assess the efficacy on clinical symptoms of LARS of low volume Transanal Irrigation by MiniGo in conjunction with conservative treatment versus conservative treatment at 3 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Adult aged from 18 years
- •Patients electively treated for rectal cancer with a low anterior resection
- •Between 3 and 18 months after the conservative colorectal surgery or 3 and 18 months after the stoma reversal if applicable
- •LARS score >= 25 (minor or major LARS) (Emmertsen and Laurberg 2012) AND LARS definition as consensus with at least one symptom that results in at least one consequence (Keane et al. 2020)
- •Adult for whom previous conservative treatments were started for at least a month
- •Mental and physical capability of the patient to handle the MiniGo by himself.
- •Check of the anastomosis (no signs of leakage or clinical relevant stenosis) and absence of local recurrence by Rectal digital examination of the anastomosis, any other exam used in the current practice
- •Patient affiliated to the health social security system
排除标准
- •Contra-indication to use TAI
- •Former use of TAI (post colo-rectal surgery)
- •Clinically relevant stenosis
- •Current metastatic disease or local recurrence
- •Ongoing chemotherapy
- •Postoperative radiotherapy for rectal cancer
- •History of diarrhoeal disease
- •Inflammatory bowel disease
- •Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant disease assessed to be a contributory cause to LARS symptoms.
- •Patient with cancer recurrence
- •Patient with a life expectancy < 1 year
- •Participating to another clinical trial for the treatment of LARS symptom
- •Ongoing pelvic floor rehabilitation/biofeedback
- •Pregnancy or intention to become pregnant during the trial period
- •Inability and unwillingness to give informed consent
结局指标
主要结局
LARS score difference
时间窗: 3-month follow-up
The primary endpoint is defined by the LARS score difference between inclusion and 3-month follow-up for each randomisation group.
次要结局
- efficacy on clinical symptom of transanal Irrigation by MiniGo in improving the LARS score at 6 weeks(6-week follow-up)
- patient health organization and resources needed at 6, 9 and 12 months(6, 9 and 12 months)
- QoL with the EORTC QLQ-C30 EORTC QLQ-CR29(3-month follow- up)
- time spent on bowel management (in the toilets room)(12 weeks)
- change (reduction) of symptoms and consequences(6 weeks and 12 weeks)
- patient satisfaction(6 weeks and 12 weeks)
- compliance of the patient to the treatmen(6 weeks and 12 weeks)
- incontinence anal score(12 weeks)
- reduction of defecations per day and night(6 weeks and 12 weeks)
- patient health organization and resources needed(12 weeks)
- improving the LARS score(6, 9 and 12 months)
- number of patients showing a change (reduction) of symptoms and consequences(6, 9 and 12 months)
- Preference of the patient and reason for it(12 month follow-up)
- QoL with the EORTC QLQ-C30 and EORTC QLQ-CR29 at 12 month(12-month follow-up)
- incontinence anal score at 12 months(12-month follow-up)
研究者
研究点 (9)
Loading locations...
相似试验
已完成
不适用
LifeVest Safety and Efficacy in Real Life Settings in FranceLeft Ventricular DysfunctionCardiac EventCardiac ArrythmiasSudden Cardiac DeathNCT03319160Zoll Medical Corporation1,164
进行中（未招募）
不适用
Essilor® Stellest® Lenses Multicentre European Study (SLOMES)MyopiaNCT06263946Essilor International150
Unknown
不适用
Post Marketing Clinical Follow up Study to Evaluate the Performance and Safety of ORTHIX PLUSDegenerative Joint Disease of KneeOsteoarthritis, KneeNCT05348525Yooyoung Pharmaceutical Co., Ltd.54
Unknown
不适用
Post Marketing Clinical Follow up Study to Evaluate the Performance and Safety of HYALEXODegenerative Joint DiseaseOsteoarthritisNCT05229458Yooyoung Pharmaceutical Co., Ltd.54
已完成
不适用
PMCF to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal SpraysURTIAllergic RhinitisNCT06104332Laboratoire de la Mer534