Knowledge-enhanced Digital Intervention to Prevent Low Anterior Resection Syndrome

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.

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Key information

Conditions

Rectal Neoplasm Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Low Anterior Resection Syndrome Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Rectal Neoplasms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile app

Other

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 anterior resection and low anterior resection are required to fill out a consent form the day before, and participants are randomly assigned to one of two groups in a 1:1 ratio: the experimental group and the control group. Both groups are randomly assigned to four surveys. The types are three quality of life assessment questionnaires (QOL (EORTC QLQ-C30, CR-29, EQ-5D-L)) and a questionnaire related to bowel symptoms (LARS). However, patients undergoing ostomy repair are excluded from the preoperati

standard

Other

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 outcomes

Incidence of low anterior resection syndrome

Time frame: 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 outcomes

Symptom change

Time frame: At patient registration and at 1, 3, 6, 12, 24, 36, and 60 months after surgery

daily bowel frequency

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

A Randomized, Multicenter Clinical Trial to Evaluate the Feasibility and Utility of a Postoperative Management App for Patients Undergoing Rectal Resection

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2032
First posted: Jun 27, 2025
Registry last updated: Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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