Comparing transanal irrigation and glycerol suppositories for treating Low Anterior Resection Syndrome
Official title: Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome: A Multicentre Randomised Controlled Trial
Run by University of Aarhus · NCT04087421 · Data updated 2026-11-12
This study is testing whether transanal irrigation or glycerol suppositories work better to help people with Low Anterior Resection Syndrome feel better after rectal cancer surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 114 (estimated) |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus) |
| Status | Recruiting |
| Started | September 17, 2019 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | May 3, 2023 |
| Trial ID | NCT04087421 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have undergone elective low anterior resection for rectal cancer and have not found relief from previous conservative treatments for LARS.
✕Probably not a fit
Patients with prior use of transanal irrigation or those with significant neurological diseases contributing to LARS symptoms may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicentre randomized controlled trial aims to compare the effectiveness of transanal irrigation (TAI) versus glycerol suppositories in patients suffering from major Low Anterior Resection Syndrome (LARS) following rectal cancer surgery. Patients who have not responded to personalized conservative treatment will be randomly assigned to receive either TAI or glycerol suppositories for a duration of 12 weeks. The primary endpoint will be assessed at the end of this treatment period to determine which method provides better symptom relief. The study will also stratify participants based on their treatment center and prior neoadjuvant radiotherapy.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from LARS, improving their quality of life.
How similar studies have gone: While transanal irrigation has been used in clinical practice, this specific comparison with glycerol suppositories is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Aarhus University Hospital, Department of Surgery
Aarhus, Denmark Recruiting
Study contacts
- Principal investigator: Peter Christensen — Research Unit, Dept. of Surgery, Aarhus University Hospital, Denmark
- Study coordinator: Mira Mekhael, M.D.
- Email: mirmek@rm.dk
- Phone: +4526213506
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.