Actively Recruiting
Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome: A Multicentre Randomised Controlled Trial
Led by University of Aarhus · Updated on 2023-05-03
114
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter randomized controlled trial to compare two treatments for patients with major Low Anterior Resection Syndrome (LARS), a condition affecting bowel function after rectal cancer surgery. The study aims to evaluate whether transanal irrigation (TAI) or glycerol suppositories provide better relief for LARS symptoms. This Phase 3 trial addresses an important question about managing persistent bowel issues after personalized conservative treatments have failed. The trial randomly assigns patients to one of two groups: one receiving daily transanal irrigation using the Qufora Irrisedo Cone System with increasing water volumes over three months, and the other administering a daily glycerol suppository to stimulate bowel movements. Treatment lasts for 12 weeks, with the first month involving 150 ml irrigation, the second month 300 ml, and the third month 500 ml for the TAI group. The glycerol suppository group uses a consistent daily dose throughout. Participants will be monitored closely during the 12-week treatment period, completing various questionnaires and assessments to measure bowel function, urinary and sexual function, quality of life, and health economics. Primary outcomes focus on changes in symptom scores using the Measure Yourself Medical Outcome Profile (MYMOP2). Additional evaluations include bowel movement frequency, incontinence episodes, and quality of life surveys, with data collected at multiple time points to track progress and safety throughout the study.
CONDITIONS
Brief 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 personalised conservative treatment after at least 4 weeks for LARS with a LARS score greater than 29
- At least 3 months after surgery including reversal of a temporary loop-ileostomy
- Age 18 years or older
- Ability to understand written and spoken language at the study site
You will not qualify if you...
- Former use of transanal irrigation
- 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 besides the rectum
- Underlying diarrhoeal disease
- Inflammatory bowel disease
- Dementia
- Significant neurologic diseases like spinal cord injury, multiple sclerosis, Parkinson's disease contributing to LARS
- Inability to use transanal irrigation
- Inability or unwillingness to give informed consent
- Pregnancy or intention to become pregnant during the trial period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive treatment with either transanal irrigation or glycerol suppositories to manage Low Anterior Resection Syndrome.
Daily use with assessments at weeks 4, 8, and 12
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.
P
Peter Christensen, Professor
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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