Qufora Irrisedo Cone System: 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.
Glycerol "OBA": Rectal suppository. Stimulates the rectum and softens and loosens stool.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
Bowel function, change in symptom 1 score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score. — 12 weeks. MYMOP2 is a validated problem-specific, patient-generated questionnaire. Patients are asked to specify one or two symptoms that concern them the most. Subsequently they evaluate the severity on a 7-point Likert scale. The second part of the questionnaire uses the same scale to assess whether the symptom limits or prevent any daily activity, and also to rate general well-being. Follow-up questionnaires address the original issues completed in the initial form. Symptom 1, symptom 2, activity, and wellbeing each have a separate score between 0 and 6 with 0 indicating "as good as it could be" and 6 "as bad as it could be". An overall score is calculated by taking the average of item scores.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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