The Safety and Efficacy of Transanal Irrigation in Patients With Sleep Disturbance From Low Anterior Resection Syndrome After Rectal Cancer Surgery: A Multicenter Prospective Randomized Controlled Trial (TraLARS)

What this Trial Is About

Researchers are investigating the effects of transanal irrigation (TAI) on sleep quality in patients who experience nighttime symptoms of Low Anterior Resection Syndrome (LARS) following rectal cancer surgery. LARS is a common condition after anal sphincter muscle preservation surgery for rectal cancer, causing bowel habit changes such as diarrhea, urgent and frequent bowel movements, and fecal incontinence. These symptoms can persist for years and significantly impact quality of life, especially sleep quality. The trial involves two groups: one receiving loperamide in the evening, a medication that slows intestinal movement to reduce diarrhea symptoms, and the other receiving the same loperamide treatment combined with TAI. TAI is a self-administered procedure where water is introduced into the rectum via an enema to physically cleanse the anus and rectum, potentially improving bowel function. This study aims to evaluate whether adding TAI can improve nighttime LARS symptoms and sleep quality. Participants will be assessed over a four-week period using tools like the LARS score for nighttime symptoms, the Insomnia Severity Index, and quality of life questionnaires. Researchers will monitor bowel and sleep symptoms, treatment adherence, and safety. The study lasts long enough to observe the short-term effects of TAI combined with loperamide compared to loperamide alone, helping to understand if TAI can better manage symptoms affecting sleep in LARS patients.

The Safety and Efficacy of Transanal Irrigation in Patients With Sleep Disturbance From Low Anterior Resection Syndrome After Rectal Cancer Surgery (TraLARS)