NCT07041515

Knowledge-enhanced Digital Intervention to Prevent Low Anterior Resection Syndrome

Not yet recruiting NA Last updated 27 June 2025

What this trial tests

NA trial testing Mobile app in Rectal Neoplasm in 320 participants. Not yet recruiting.

Timeline

1 July 2025

Primary endpoint
30 January 2028

30 January 2032

Quick facts

Lead sponsor	National Cancer Center, Korea
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	320
Start date	1 July 2025
Primary completion	30 January 2028
Estimated completion	30 January 2032

Drugs / interventions tested

• Mobile app
• standard

Conditions studied

• Rectal Neoplasm — all drugs for Rectal Neoplasm →

Sponsor

National Cancer Center, Korea

Who can join

Adults 20 to 70, any sex, with Rectal Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. K-LARS trial: protocol for a multicentre randomised controlled trial evaluating a knowledge-enhanced digital intervention to prevent low anterior resection syndrome in Korea.
   Ryoo SB, Ahn HM, Nam BH, Song YM, et al · · 2025 · PMID 41320216 · DOI 10.1136/bmjopen-2025-107819