NCT04087421 Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
| NCT ID | NCT04087421 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Aarhus |
| Condition | Low Anterior Resection Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 114 participants |
| Start Date | 2019-09-17 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 114 participants in total. It began in 2019-09-17 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Peter Christensen
PRINCIPAL INVESTIGATOR
Research Unit, Dept. of Surgery, Aarhus University Hospital, Denmark
Frequently Asked Questions
Who can join the NCT04087421 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Low Anterior Resection Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04087421 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 114 participants.
Is NCT04087421 currently recruiting?
Yes, NCT04087421 is actively recruiting participants. Contact the research team at mirmek@rm.dk for enrollment information.
Where is the NCT04087421 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT04087421 clinical trial?
NCT04087421 is sponsored by University of Aarhus. The principal investigator is Peter Christensen at Research Unit, Dept. of Surgery, Aarhus University Hospital, Denmark. The trial plans to enroll 114 participants.