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Recruiting Phase 3 NCT04087421

Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome

Trial Parameters

Condition Low Anterior Resection Syndrome
Sponsor University of Aarhus
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 114
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2019-09-17
Completion 2026-12
Interventions
Qufora Irrisedo Cone SystemGlycerol "OBA"

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 pa

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