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Tests treatment safety and results for Low Anterior Resection Syndrome
Official title The Safety and Efficacy of Transanal Irrigation in Patients With Sleep Disturbance From Low Anterior Resection Syndrome After Rectal Cancer Surgery (TraLARS)
ClinicalTrials.gov ID: NCT06222255
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 80
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Jongro-gu, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Jongro-gu, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.