Effect of the Automatic Surveillance System on Surveillance Rate of Colorectal Postpolypectomy Patients

Обзор

In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of colorectal postpolypectomy patients. The enrolled patients were divided into group A with intelligent surveillance system reminding though telephone and message, group B with intelligent surveillance system reminding though message, group C with manual reminder, and group D with natural state. The surveillance among the four groups were compared.

Подробное описание

The adherence of doctors to published colorectal post-polypectomy surveillance guidelines varies greatly, and patient follow-up is critical but time-consuming. Previous studies we developed an automatic surveillance (AS) system to accurately identify post-polypectomy patients, assign surveillance intervals for different risks of patients and proactively follow up with patients in time. In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of colorectal postpolypectomy patients. The enrolled patients were divided into group A with intelligent surveillance system reminding though telephone and message, group B with intelligent surveillance system reminding though message, group C with manual reminder, and group D with natural state. The surveillance among the four groups were compared.

Вмешательства

• Другое AI based automatic surveillance (AS) system (ENDOANGEL-AS) reminds the patients through by telephone .
  An automatic surveillance (AS) system to accurately identify post-polypectomy patients, assign surveillance intervals for different risks of patients and proactively follow up with patients at certain times. AI based automatic surveillance (AS) system (ENDOANGEL-AS) reminds patients by telephone.
• Другое AI based automatic surveillance (AS) system (ENDOANGEL-AS) reminds the patients through message.
  An automatic surveillance (AS) system to accurately identify post-polypectomy patients, assign surveillance intervals for different risks of patients and proactively follow up with patients at certain times. AI based automatic surveillance (AS) system (ENDOANGEL-AS) reminds patients through message.
• Другое Manually remind the patients
  Medical staff remind patients manually .

Первичные конечные точки

• On-time Surveillance Rate [Срок оценки: From enrollment to study completion, assessed up to 3 years.]

Вторичные конечные точки (11)

• Surveillance Rate [Срок оценки: From enrollment to study completion, assessed up to 3 years.]
• Advance Surveillance Rate [Срок оценки: From enrollment to study completion, assessed up to 3 years.]
• Delayed Surveillance Rate [Срок оценки: From enrollment to study completion, assessed up to 3 years.]
• The accuracy of identifing post-polypectomy patients [Срок оценки: 1 day At the time of enrollment]
• The accuracy of classifying risk levels [Срок оценки: 1 day At the time of enrollment]
• The accuracy of assigning surveillance intervals [Срок оценки: 1 day At the time of enrollment]
• lesion progression rate [Срок оценки: From enrollment to study completion, assessed up to 3 years.]
• lesion persistence rate [Срок оценки: From enrollment to study completion, assessed up to 3 years.]
• lesion regression rate [Срок оценки: From enrollment to study completion, assessed up to 3 years.]
• The incidence rate of early colorectal cancer [Срок оценки: From enrollment to study completion, assessed up to 3 years.]
• The incidence rate of colorectal cancer [Срок оценки: From enrollment to study completion, assessed up to 3 years.]

Критерии участия

Критерии включения

• Male or female aged 18 years or older who undergo colonoscopy.

Критерии исключения

• 1)No pathological result.
• 2\) No or invalid contact information.
• 3\) The surveillance interval cannot be determined according to the surveillance guidelines, including poor bowel preparation, colorectal cancer or suspicious malignance, surgery or colorectal ESD history, those who fail to complete colonoscopy due to unbearable, pathological indications of not polyps, hamartoma or lymphoma polyps, history of ulcerative colitis, and so on.
• 4\) Has participated in other clinical trials, signed the informed consent form and is in the surveillance period of other clinical trials.
• 5\) Have drug or alcohol abuse or psychological disorder in the past five years.
• 6）Pregnancy.
• 7）Not suitable for recruitment after investigator evaluation because of other high-risk conditions.

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

Двойное слепое

Основная цель

Скрининг

Центры проведения

Китай · 1 центр

• Renmin Hospital of Wuhan University — Ухань

Идентификаторы

NCT: NCT05894850 · EA-19-003-29

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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