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

Rectal Cancer Clinical Trial

Official title:
Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome: A Multicentre Randomised Controlled Trial

Clinical Trial 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).

Clinical Trial Description

Transanal irrigation (TAI) is used as a second-line treatment following unsuccessful personalised conservative treatment (PCT) of LARS. However, it is unknown if scheduled, initiated defecation with the aid of a glycerol suppository will have the same clinical effect as TAI. Thus, the aim of this study is to compare the effect of TAI with a glycerol suppository in patients suffering from major LARS. The study is a multi-centre, randomised, controlled, 12 weeks, parallel-group trial comparing treatment with TAI to treatment with glycerol suppositories. Patients will be randomised - stratified by centre and neoadjuvant radiotherapy - in a 1:1 ratio to receive treatment with TAI or glycerol suppositories. Primary endpoint will be assessed by the end of week twelve. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04087421
Study type Interventional
Source University of Aarhus
Contact Mira Mekhael, M.D.
Phone +4526213506
Email mirmek@rm.dk
Status Recruiting
Phase Phase 3
Start date September 17, 2019
Completion date December 2026
View Details
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