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

RecruitingNAAges 19 Years - 80 YearsAllSeoul National University Hospital
NCT06222255 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The preservation surgery of the anal sphincter muscle has become the standard procedure in the treatment of rectal cancer and, thanks to advancements in surgical techniques, can now be performed for tumors located closer to the anus. This method allows patients to avoid a permanent artificial anus, maintaining continuity of the intestines and enabling bowel movements through the anus, making it a highly preferred procedure. Furthermore, advancements in various tumor treatments have led to improved long-term survival rates. Preservation surgery of the anal sphincter muscle is commonly used in the treatment of rectal cancer, resulting in approximately 90% of patients experiencing changes in bowel habits after surgery. These changes include characteristic diarrhea, urgent bowel movements, frequent bowel movements, and fecal incontinence, collectively known as Anterior Resection Syndrome (A

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📋 Eligibility rules (as published)
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.
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What it tests

  • Transanal Irrigation (TAI)
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Where

1 site
Seoul National University Hospital
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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