Actively Recruiting
Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
Led by University of Aarhus · Updated on 2023-05-03
114
Participants Needed
1
Research Sites
376 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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).
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Aarhus University Hospital, Department of Surgery
Aarhus, Denmark, 8200
Actively Recruiting
Research Team
M
Mira Mekhael, M.D.
CONTACT
P
Peter Christensen, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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