Transanal irrigation for sleep issues after rectal cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and efficacy of transanal irrigation (TAI) in patients suffering from sleep disturbances due to Low Anterior Resection Syndrome (LARS) following rectal cancer surgery. The study focuses on adults who have undergone preservation surgery for rectal cancer and are experiencing significant changes in bowel habits, which can lead to insomnia and other sleep disorders. Participants will be evaluated based on their LARS and Insomnia Severity Index (ISI) scores to determine the impact of TAI on their symptoms. The trial aims to provide a potential therapeutic option for improving quality of life in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Seoul National University Hospital
  Seoul, Jongro-gu, South Korea Recruiting

Study contacts

• Study coordinator: Seung-Bum Ryoo, MD. PhD
• Email: sbryoomd@gmail.com
• Phone: +82-2-2072-4847

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.