Knowledge-enhanced Digital Intervention to Prevent Low Anterior Resection Syndrome

Not Applicable

Not yet recruiting

• Conditions: Rectal Neoplasm

• Registration Number: NCT07041515
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-19
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-27
• Last Update Posted: 2025-06-27
• Study Start: 2025-07-01
• Primary Completion: 2028-01-30
• Study Completion: 2032-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

1. Adults aged 20-70 years
2. Patients scheduled for anal-sparing rectal resection or stomy repair diagnosed with rectal cancer (within 15 cm from Anal Verge)
3. Patients with an expected survival period of 1 year or more
4. Patients or their primary caregivers use smartphones (apps)
5. Patients who are aware of their own status and can provide consent for this study

Exclusion Criteria

1. If you are receiving chemotherapy or radiotherapy at the time of consent
2. If you are scheduled for major colectomy such as total colectomy or partial colectomy in addition to rectal resection
3. If you cannot be contacted by phone
4. If you cannot read and understand Korean
5. If you cannot provide consent based on clear and sufficient information

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of low anterior resection syndrome	1 year after surgery	The incidence of high-risk low anterior resection syndrome with a score of 30 to 42 in the bowel symptom questionnaire

Secondary Outcome Measures

Name	Time	Method
Symptom change	At patient registration and at 1, 3, 6, 12, 24, 36, and 60 months after surgery	daily bowel frequency