Comparison of transanal irrigation and glycerol suppository in treatment of Low Anterior Resection Syndrome: A multicentre randomised controlled trial

Department of Surgery, Aarhus University Hospital0 个研究点目标入组 114 人开始时间: 2019年5月28日最近更新: 2019年11月25日

试验速览

暂无简介。

•1.Patients electively treated for rectal cancer with a low anterior resection.
•2.Unsuccessful PCT after at least 4 weeks of treatment for LARS (LARS score >29 at evaluation).
•3.At least 3 months after surgery (including reversal of a temporary loop-ileostomy).
•4.Age > 18 years
•5.Ability to understand written and spoken language actual for the including site (due to questionnaire validity).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 57
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 57

•1.Former use of TAI
•2.Anastomotic stenosis
•3.History of anastomotic leakage
•4.Current metastatic disease or local recurrence
•5.Ongoing oncological treatment
•6.Postoperative radiotherapy for rectal cancer
•7.Previous or current cancer in the pelvic organs
•8.Underlying diarrhoeal disease
•9.Inflammatory bowel disease
•10.Symptom 1 in MYMOP cannot be classified as a LARS symptom
•11.Dementia
•12.Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant neurologic disease assessed to be a contributory cause to LARS symptoms.
•13.Inability of patient to use TAI
•14.Inability and unwillingness to give informed consent
•15.Pregnancy or intention to become pregnant during the trial period

发起方

Department of Surgery, Aarhus University Hospital