Compares two treatments for bowel problems after rectal cancer surgery
Compares transanal irrigation with glycerol suppositories in adults with Low Anterior Resection Syndrome.
Plain-language title generated from the registry record
Registry title: Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
Key facts
- Where
- Aarhus, DenmarkSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had surgery for rectal cancer and still have major bowel problems called Low Anterior Resection Syndrome (LARS). It compares transanal irrigation with glycerol suppositories.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Treated for rectal cancer with a low anterior resection, at least 3 months after surgery (including reversal of a temporary loop-ileostomy). Major LARS with a LARS score >29.
- Earlier treatment
- Earlier treatment for LARS for at least 4 weeks did not work (PCT was unsuccessful). Cannot have used TAI before or regularly used rectal emptying aids.
- Biomarker or test result
- LARS score >29 at evaluation.
Main reasons for not taking part
- Narrowing at the join of the bowel (anastomotic stenosis) or a past leak there
- Current metastatic disease or local recurrence, or ongoing cancer treatment
- Postoperative radiotherapy for rectal cancer
- Diarrhoeal disease, inflammatory bowel disease, dementia, or a nerve disease that contributes to LARS symptoms
- Pregnancy or intention to become pregnant during the trial
Read by machine on 9 November 2026.
Where in Denmark
- Aarhus University Hospital, Department of SurgeryAarhus, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Aarhus
- Trial code
- NCT04087421
- Record updated
- 3 May 2023
- Original 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).Read full original descriptionShow less
Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome: A Multicentre Randomised Controlled Trial
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).
Inclusion: 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: Prior systematic use of rectal emptying aids; Previous or current cancer in other pelvic organs than the rectum; History of anastomotic leakage; Current metastatic disease or local recurrence; Postoperative radiotherapy for rectal cancer; 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; Former use of TAI; Anastomotic stenosis; Ongoing oncological treatment; Inability of patient to use TAI; Inability and unwillingness to give informed consent; Pregnancy or intention to become pregnant during the trial period.