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

Recruiting now · Phase 3

Conditions studied: Low Anterior Resection Syndrome, Rectal Cancer

In brief

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).

Key facts

Study ID

NCT04087421

Run by

University of Aarhus

People needed

114

Starts

2019-09-17

Expected to finish

2026-12-01

Last updated by the study team

2023-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Aarhus University Hospital, Department of Surgery — Aarhus, Denmark (enrolling)

Full record on ClinicalTrials.gov

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