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

Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome: A Multicentre Randomised Controlled 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).

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.

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