Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome: A Multicentre Randomised Controlled Trial
University of Aarhus
114 participants
Sep 17, 2019
INTERVENTIONAL
Conditions
Summary
The study is a multicentre randomized controlled trial with the objective to compare the effect of transanal irrigation with glycerol suppositories in patients suffering from major Low Anterior Resection Syndrome (LARS).
Eligibility
Inclusion Criteria5
- Patients electively treated for rectal cancer with a low anterior resection.
- Unsuccessful PCT after at least 4 weeks of treatment for LARS (LARS score \>29 at evaluation).
- At least 3 months after surgery (including reversal of a temporary loop-ileostomy).
- Age \>= 18 years
- Ability to understand written and spoken language actual for the including site (due to questionnaire validity).
Exclusion Criteria15
- Former use of TAI
- Prior systematic use of rectal emptying aids
- Anastomotic stenosis
- History of anastomotic leakage
- Current metastatic disease or local recurrence
- Ongoing oncological treatment
- Postoperative radiotherapy for rectal cancer
- Previous or current cancer in other pelvic organs than the rectum
- Underlying diarrhoeal disease
- Inflammatory bowel disease
- Dementia
- Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant neurologic disease assessed to be a contributory cause to LARS symptoms.
- Inability of patient to use TAI
- Inability and unwillingness to give informed consent
- Pregnancy or intention to become pregnant during the trial period
Interventions
The system works by connecting a tube from a water bag to a cone. The cone is placed into the rectum and the prescribed water volume is pumped into the rectum. When the water has been installed the valve is closed and the cone removed. Residual water and stool will then flow into the toilet.
Rectal suppository. Stimulates the rectum and softens and loosens stool.
Locations(1)
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NCT04087421