Clinical trial
Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome: A Multicentre Randomised Controlled Trial
Name
676869
Description
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).
Trial arms
Trial start
2019-09-17
Estimated PCD
2026-12-01
Trial end
2026-12-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Transanal irrigation
Glycerol "OBA"
Rectal suppository. Stimulates the rectum and softens and loosens stool.
Arms:
Glycerol suppositories
Size
114
Primary endpoint
Bowel function, change in symptom 1 score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score.
12 weeks.
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 114, 'type': 'ESTIMATED'}}
Updated at
2023-05-03
1 organization
Organization
Aarhus University