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Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
RECRUITINGPhase 3Sponsored by University of Aarhus
Actively Recruiting
PhasePhase 3
SponsorUniversity of Aarhus
Started2019-09-17
Est. completion2026-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04087421
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions3
CancerLow Anterior Resection SyndromeRectal Cancer
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Actively Recruiting
PhasePhase 3
SponsorUniversity of Aarhus
Started2019-09-17
Est. completion2026-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT04087421