Transanal irrigation for sleep issues after rectal cancer surgery

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)

This study tests if a treatment called transanal irrigation can help adults with sleep problems after surgery for rectal cancer feel better and improve their sleep.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 19 Years to 80 Years
• Sex: All
• Sponsor: Seoul National University Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Seoul, Jongro-gu)
• Trial ID: NCT06222255 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 and older who have undergone low or ultra-low anterior resection surgery for rectal cancer and are experiencing sleep disturbances related to LARS.

Not a fit: Patients who have had prior surgeries for colorectal cancer or those currently taking medication for LARS may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve sleep quality and overall well-being for patients affected by LARS after rectal cancer surgery.

How similar studies have performed: While the specific approach of using transanal irrigation for sleep disturbances in this context is novel, similar interventions have shown promise in managing bowel-related symptoms in other studies.

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.

Where this trial is running

Seoul, Jongro-gu

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

Study contacts

• Study coordinator: Seung-Bum Ryoo, MD. PhD

Conditions Low Anterior Resection Syndrome; Rectal Cancer; Insomnia; Sleep Disorder