NCT07041515Not yet recruiting
Knowledge-enhanced Digital Intervention to Prevent Low Anterior Resection Syndrome
A Randomized, Multicenter Clinical Trial to Evaluate the Feasibility and Utility of a Postoperative Management App for Patients Undergoing Rectal Resection
Source: ClinicalTrials.gov · Last updated 27 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Low anterior resection syndrome refers to changes in bowel habits such as frequent defecation, urgent defecation, and fecal incontinence, which result in decreased bowel function. It occurs very commonly after surgery for colorectal cancer, especially rectal cancer, and symptoms appear severely immediately after surgery, followed by a recovery process. It is known that symptoms improve significantly after one year of surgery, but in some patients, symptoms persist, which significantly affects the quality of life and causes social problems. There is no established treatment method for low anterior resection syndrome, and accurate evaluation and customized treatment are required according to the patient's surgical or radiotherapy treatment content and symptoms. It is also important to monitor the change in symptoms during the treatment process, and a customized step-by-step treatment strategy for such patients is required. However, such a customized step-by-step treatment strategy for such patients is very complex, and there are no clear guidelines to date, and the research design for some clinical trials has been recently reported. The purpose of this study was to develop an app-based Patient-Reported Outcome (PRO) standardized questionnaire for patients after rectal cancer surgery to systematically collect and monitor symptom information, establish a multidisciplinary management plan tailored to patients, and provide education and treatment to improve the quality of life of rectal cancer survivors. A management program utilizing a research device (app) can reduce the incidence of Major LARS after rectal cancer surgery compared to standard treatment.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 19 Apr 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 30 Jan 2028
- Lead sponsor
- National Cancer Center, Korea
- Diseases
- Colorectal cancer
- NCT number
- NCT07041515
What you commit to
- Study type: Interventional
- Planned participants: 320
- From 1 Jul 2025 to the primary completion date, 30 Jan 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- If you are receiving chemotherapy or radiotherapy at the time of consent
- If you are scheduled for major colectomy such as total colectomy or partial colectomy in addition to rectal resection
Other
- If you cannot be contacted by phone
- If you cannot read and understand Korean
- If you cannot provide consent based on clear and sufficient information
Who the study is looking for
- Adults aged 20-70 years
- Patients scheduled for anal-sparing rectal resection or stomy repair diagnosed with rectal cancer (within 15 cm from Anal Verge)
- Patients with an expected survival period of 1 year or more
- Patients or their primary caregivers use smartphones (apps)
- Patients who are aware of their own status and can provide consent for this study
Age in the registry: 20 years to 70 years · Sex: All · Does not accept healthy volunteers
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.