Transanal Irrigation - Best Treatment Possibility for Low Anterior Resection Syndrome? Multicenter, Randomized Clinical Trial

Launched by NATIONAL CANCER CENTER AFFILIATE OF VILNIUS UNIVERSITY HOSPITAL SANTAROS KLINIKOS · Jun 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called transanal irrigation to see if it can help improve bowel function and quality of life for patients who have problems after undergoing surgery for rectal cancer, a condition known as Low Anterior Resection Syndrome (LARS). Many patients experience severe issues with bowel control after this type of surgery, and this study aims to find out if a new method of flushing the bowel could be more effective than the best current supportive care.

To participate, you need to be an adult who has had a low anterior resection surgery more than a year ago and is currently experiencing significant LARS symptoms. The trial will involve regular visits where you'll complete questionnaires about your bowel issues and overall quality of life for a year. This will help researchers understand how well transanal irrigation works compared to other types of care. It's an important study that could lead to better treatment options for people suffering from LARS in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject is an adult (≥ 18 years);
• • Agrees to participate in a study;
• • A low anterior resection (robotic, laparoscopic or open) was performed (anastomosis up to 5-7 cm from the anocutaneous line when assessed with a finger or endo(recto)scope);
• • \>12 months have passed since the operation or the closure of the ileostomy (if formed);
• • No anastomotic leak or stenosis (assessed clinically, during examination, and/or proctogram);
• • LARS \>30 points (major LARS).
• Exclusion Criteria:
• • Tumor recurrence/progression
• • Pregnancy
• • Diagnosed with inflammatory bowel disease (ICD codes K50-59).
• • Side-to-end anastomosis
• • Palliative care
• • Will not be able to perform irrigation