Status:
RECRUITING
The Safety and Efficacy of Transanal Irrigation in Patients With Sleep Disturbance From Low Anterior Resection Syndrome After Rectal Cancer Surgery (TraLARS)
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Seoul National University Bundang Hospital
SMG-SNU Boramae Medical Center
Conditions:
Low Anterior Resection Syndrome
Rectal Cancer
Eligibility:
All Genders
19-80 years
Phase:
NA
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- Adults aged 19 years and above.
- Patients who have undergone low or ultra-low anterior resection surgery for rectal cancer (within 15cm from the anal verge).
- 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).
- Patients evaluated with a major LARS score who also have an ISI score of 3 or 4.
- Patients who comprehend and have the ability to participate in this clinical trial.
Exclusion
- Patients currently taking medication for LARS within the last month.
- Patients with a history of prior surgery for colorectal cancer.
- Patients with recurrent colorectal cancer.
- Patients with concomitant metastatic colorectal cancer.
- Patients requiring permanent colostomy.
- Patients who have undergone postoperative cancer radiation therapy.
- Patients with underlying conditions not controlled by internal medical treatment.
- Patients with inflammatory bowel disease (IBD).
- Patients with symptoms of constipation or diarrhea not controlled by medication.
- Patients with preoperative symptoms of fecal incontinence.
- Patients allergic to the investigational drug.
- Patients deemed unsuitable for clinical trial participation by the principal investigator and study personnel.
- Patients with ISI scores of 1 or 2.
Key Trial Info
Start Date :
December 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06222255
Start Date
December 6 2023
End Date
December 31 2028
Last Update
January 24 2024
Active Locations (1)
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1
Seoul National University Hospital
Seoul, Jongro-gu, South Korea, 03080