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

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Jan 22, 2024

Keywords

ClinConnect Summary

The TraLARS clinical trial is investigating whether a treatment called transanal irrigation (TAI) can help improve sleep quality for patients suffering from Low Anterior Resection Syndrome (LARS) after rectal cancer surgery. LARS can cause troublesome bowel symptoms, especially at night, which often lead to sleep disturbances. In this study, researchers want to see if using TAI, which involves flushing the rectum with water to relieve bowel issues, can reduce these nighttime symptoms and help patients sleep better.

To participate in this trial, you need to be an adult aged 19 or older who has had specific types of rectal cancer surgery at least two years ago. You should also have symptoms of LARS affecting your sleep. However, some patients may not be eligible, such as those currently taking medications for LARS or with certain medical conditions. If you join the study, you can expect to learn more about how TAI might improve your nighttime symptoms and overall quality of life. The trial is currently recruiting participants, and your involvement could help others facing similar challenges in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults aged 19 years and above.
• • 2. Patients who have undergone low or ultra-low anterior resection surgery for rectal cancer (within 15cm from the anal verge).
• • 3. Patients at least 24 months post-surgery (excluding those with incontinence, patients who have undergone postoperative cancer treatment should have completed treatment, and patients who have undergone bowel restoration surgery should be at least 6 months post-surgery, or for patients who received long-course preoperative radiotherapy, at least 18 months post-surgery).
• • 4. Patients evaluated with a major LARS score who also have an ISI score of 3 or 4.
• • 5. Patients who comprehend and have the ability to participate in this clinical trial.
• Exclusion Criteria:
• • 1. Patients currently taking medication for LARS within the last month.
• • 2. Patients with a history of prior surgery for colorectal cancer.
• • 3. Patients with recurrent colorectal cancer.
• • 4. Patients with concomitant metastatic colorectal cancer.
• • 5. Patients requiring permanent colostomy.
• • 6. Patients who have undergone postoperative cancer radiation therapy.
• • 7. Patients with underlying conditions not controlled by internal medical treatment.
• • 8. Patients with inflammatory bowel disease (IBD).
• • 9. Patients with symptoms of constipation or diarrhea not controlled by medication.
• • 10. Patients with preoperative symptoms of fecal incontinence.
• • 11. Patients allergic to the investigational drug.
• • 12. Patients deemed unsuitable for clinical trial participation by the principal investigator and study personnel.
• • 13. Patients with ISI scores of 1 or 2.