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

Launched by UNIVERSITY OF AARHUS · Sep 10, 2019

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for patients who have Low Anterior Resection Syndrome (LARS), a condition that can occur after surgery for rectal cancer. The trial is comparing transanal irrigation, a method that uses water to help clear the bowel, with glycerol suppositories, which are small medications inserted into the rectum to help with bowel movements. The goal is to find out which treatment is more effective in managing the symptoms of LARS.

To participate, you need to be at least 18 years old and have had surgery for rectal cancer, specifically a procedure called low anterior resection. You should also have experienced LARS symptoms that did not improve with other treatments for at least 4 weeks. Participants will be randomly assigned to receive either the transanal irrigation or glycerol suppositories, and they will be monitored to see how well each treatment works. This trial is currently recruiting patients, and it's important to note that certain health conditions or past treatments may make someone ineligible to participate. If you're considering joining, you will have the chance to learn more about both treatments and contribute to important research that could help others in the future.

Gender

ALL

Eligibility 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