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

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Aarhus
• Treatments: Glycerol

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 patient to use TAI

• Inability and unwillingness to give informed consent

• Pregnancy or intention to become pregnant during the trial period