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

Recruiting Phase 3 Interventional Study
Low Anterior Resection Syndrome Rectal Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
114 (estimated)
Sponsor
University of Aarhus · Other
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About This 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).

Trial Locations
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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 year…
Contacts

Mira Mekhael, M.D.

+4526213506

mirmek@rm.dk

CONTACT

Peter Christensen, Professor

petchris@rm.dk

CONTACT