Knowledge-enhanced Digital Intervention to Prevent Low Anterior Resection Syndrome

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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
• Другое 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.

Первичные конечные точки

• Incidence of low anterior resection syndrome [Срок оценки: 1 year after surgery]

Вторичные конечные точки (1)

• Symptom change [Срок оценки: At patient registration and at 1, 3, 6, 12, 24, 36, and 60 months after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT07041515 · NCC2025-0022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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