Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
Former use of TAI
Prior systematic use of rectal emptying aids
Anastomotic stenosis
History of anastomotic leakage
Trial design
Treatments tested in this trial
- Qufora Irrisedo Cone System
- Glycerol "OBA"
Treatment groups
114 Participants
are divided into 2 treatment groupsLocations
1Aarhus University Hospital, Department of Surgery8200, Aarhus Denmark
Sponsors and collaborators
University of Aarhus
Lead sponsor
Source ClinicalTrials.gov