Transanal Irrigation - Best Treatment Possibility for Low Anterior Resection Syndrome? Multicenter, Randomized Clinical Trial
Low Anterior Resection Syndrome
About this trial
This is an interventional supportive care trial for Low Anterior Resection Syndrome focused on measuring Low Anterior Resection Syndrome, Transanal irrigation, Fecal Incontinence, Colorectal Surgery, Quality of Life, Randomized Controlled Trial
Eligibility Criteria
Inclusion Criteria: Subject is an adult (≥ 18 years); Agrees to participate in a study; A low anterior resection (robotic, laparoscopic or open) was performed (anastomosis up to 5-7 cm from the anocutaneous line when assessed with a finger or endo(recto)scope); >12 months have passed since the operation or the closure of the ileostomy (if formed); No anastomotic leak or stenosis (assessed clinically, during examination, and/or proctogram); LARS >30 points (major LARS). Exclusion Criteria: Tumor recurrence/progression Pregnancy Diagnosed with inflammatory bowel disease (ICD codes K50-59). Side-to-end anastomosis Palliative care Will not be able to perform irrigation
Sites / Locations
- National Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Transanal irrigation group
Best supportive care group
Transanal irrigation will be applied to patients who will enter the experimental group. The patient lies on the left or right side, depending on the main hand, the knees are bent. With the main hand, he carefully introduces the TAI tip lubricated with lubricant. The TAI bag is filled with warm water - it can be boiled or just from the tap. The contents of the TAI bag are slowly administered through the anus. The duration of the TAI is about 15-20 minutes. Afterwards, the subject goes to defecate until the bowel is empty. This action should be repeated daily.
The control group will receive best supportive care (diet modification, Loperamidum if needed, diapers, etc). Loperamidum Dosage form: Loperamide Tablets (2mg of loperamide hydrochloride.). Dosage: Initial dose - 2 tablets immediately, then - 1 tablet after each loose stool, but not earlier than 2-3 hours after the initial dose. Do not exceed the maximum daily dose - no more than 6 tablets for adults (maximum daily dose 12 mg).