Prospective Collection and Registry Study of Multicenter, Multidisciplinary Surgical Minimally Invasive Videos

Официальное название

Prospective Observational Cohort Study on the Construction of Standardized Video Datasets for Multicenter, Multidisciplinary Minimally Invasive Laparoscopic and Robotic Surgery and Their Application in the Development of Surgical AI Large Models

Обзор

This is a prospective multicenter patient registry study. We continuously collect full-length intraoperative surgical videos from thoracoscope, laparoscope, hysteroscope, transcervical resectoscope, cystoscope, prostate resectoscope, arthroscope, intervertebral foramen endoscope, otorhinolaryngology endoscope and endoscopic surgical robots, accompanied by inpatient medical records, preoperative imaging data and 5-year postoperative follow-up data. All imaging data will be standardized and de-identified to construct a large-scale standardized surgical video dataset. The dataset will be applied for training, verification and optimization of surgical video foundation large model, serving for surgical teaching, intraoperative operation quality control and basic medical AI research. We will also explore the correlation between intraoperative surgical details and postoperative prognosis to improve the standard specifications of minimally invasive surgery. No clinical intervention will be imposed on participants throughout the whole research.

Первичные конечные точки

• Completion rate of qualified intraoperative surgical imaging data [Срок оценки: Immediately after each surgery]

Вторичные конечные точки (4)

• Completeness rate of long-term postoperative clinical follow-up [Срок оценки: 3 months, 1 year, 3 years and 5 years after surgery]
• Reusability rate of annotated key anatomical structures in videos [Срок оценки: From completion of data warehousing and annotation, the reusability rate will be analyzed within 3 months, assessed up to 3 months after annotation completion.]
• Feasibility rate (%) of surgical video dataset applied in different clinical AI research scenarios [Срок оценки: After full construction of the surgical video dataset, scenario feasibility assessment will be finished within 6 months, assessed up to 6 months after dataset construction.]
• Accuracy percentage (%) of AI-based surgical procedure identification on annotated surgical videos [Срок оценки: After completion of data warehousing and annotation, AI surgical procedure identification accuracy testing will be conducted within 3 months, assessed up to 3 months post annotation completion.]

Критерии участия

Критерии включения

• Patients aged ≥ 18 years old hospitalized to receive minimally invasive endoscopic, laparoscopic or robotic surgical treatment for diseases of various body systems;
• Complete full-length intraoperative surgical videos can be recorded during operation, with complete medical records and preoperative imaging data;
• Participants fully understand the study, voluntarily sign written informed consent, and agree that their de-identified intraoperative images and clinical data can be used for scientific research.

Критерии исключения

• Minors under 18 years of age;
• Patients with incomplete intraoperative videos or missing clinical imaging documents;
• Patients with consciousness disturbance or mental disorders who cannot sign informed consent independently;
• Subjects who refuse to participate in the study and disapprove the use of their medical data for research;
• Patients who are predicted to be unavailable for long-term postoperative follow-up.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Institute of Automation, Chinese Academy of Sciences — Пекин

Идентификаторы

NCT: NCT07752862 · VISION

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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