Knowledge-enhanced Digital Intervention to Prevent Low Anterior Resection Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mobile app, standard.
- Who it may be relevant to
- Registry conditions: Rectal Neoplasm. Basic parameters: 20 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Multicenter Clinical Trial to Evaluate the Feasibility and Utility of a Postoperative Management App for Patients Undergoing Rectal Resection
Overview
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.
Interventions
- Other Mobile app
This study will be conducted in two stages, recruiting patients scheduled for low anterior resection and those scheduled for ostomy restoration after low anterior resection. The pilot stage study will recruit 20 subjects without randomization to evaluate the feasibility of the management program app, and the second stage study will be a parallel experimental-control study, recruiting approximately 300 research participants, 150 from each group. Patients scheduled for ostomy repair after low ant - Other standard
Subjects classified as control group will receive educational materials. One month and three months after surgery, a questionnaire related to bowel symptoms (LARS) will be administered by phone. The researcher will call the subjects and administer it according to the period. The results of the questionnaire related to bowel symptoms (LARS) administered by phone will be confirmed by the medical staff during outpatient treatment.
Primary outcome measures
- Incidence of low anterior resection syndrome [Time frame: 1 year after surgery]
Secondary outcome measures (1)
- Symptom change [Time frame: At patient registration and at 1, 3, 6, 12, 24, 36, and 60 months after surgery]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Ryoo SB, Ahn HM, Nam BH, Song YM, Sohn DK. K-LARS trial: protocol for a multicentre randomised controlled trial evaluating a knowledge-enhanced digital intervention to prevent low anterior resection syndrome in Korea. BMJ Open. 2025 Nov 29;15(11):e107819. doi: 10.1136/bmjopen-2025-107819. PMID 41320216
Identifiers
NCT: NCT07041515 · NCC2025-0022