Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
About this study
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).
- Condition
- Low Anterior Resection Syndrome, Rectal Cancer
- Tested
- Qufora Irrisedo Cone System, Glycerol "OBA"
- Sponsor
- University of Aarhus
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
Inclusion 7
- Minimum age: 18 years
- Study condition: Low Anterior Resection Syndrome, Rectal Cancer
- 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 15
- 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
Where
1 site, 1 recruiting
Aarhus University Hospital, Department of Surgery
Aarhus, Denmark
Contact
-
Mira Mekhael, M.D.
+4526213506 mirmek@rm.dk
-
Peter Christensen, Professor
Potential match only. Final eligibility is determined by the study team.