Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery

Официальное название

Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery - a First-in-human Interventional Study

Обзор

The aim of the study is to evaluate the technical feasibility and applicability of a surgical assistance system based on image recognition algorithms in a first-in-human pilot study. In addition, this study will provide preliminary data on the oncological outcome of the assistance system.

Вмешательства

• Другое Additional visualisation of surgical assistance during surgery
  Robot-assisted anterior rectal resection using daVinci® system as CE-marked gold standard with additional visualization of surgical assistance functions based on machine learning techniques

Первичные конечные точки

• Incidence of discrepancies between the surgeon's preparation and the prediction of the CoBot system [Срок оценки: 72 hours after Surgery]

Вторичные конечные точки (11)

• Operating time [min] [Срок оценки: During Surgery]
• Duration of postoperative hospital stay [days] [Срок оценки: At day of discharge, assessed up to 5 days]
• Duration of postoperative intermediate/intensive care unit stay [days] [Срок оценки: At day of discharge, assessed up to 5 days]
• Frequency of peri-operative morbidity after resection [Срок оценки: At day of discharge, assessed of up to 5 days]
• Kind of peri-operative morbidity after resection [Срок оценки: At day of discharge, assessed of up to 5 days]
• Assessment of the circumferential resection margin (CRM) [Срок оценки: At day of discharge, assessed up to 5 days]
• Number of resected lymphnodes [Срок оценки: During surgery]
• Assessment of pelvic function before and after rectal resection [Срок оценки: 15 months]
• Rectal sphincter function before and after rectal resection [Срок оценки: 15 months]
• Assessment of the difficulty of the preparation [Срок оценки: 48 hours after surgery]
• Assessment of usability of guidance system [Срок оценки: Through study completion, an average of 6 months]

Критерии участия

Критерии включения

• Patients with rectal cancer scheduled for robot-assisted rectal resection
• Intact preoperative urogenital/rectal function
• Full capability of consent

Критерии исключения

• Previous/Second malignant disease <5 years before diagnosis of rectal cancer
• Previous abdominal surgery, except for laparoscopic appendectomy, laparoscopic cholecystectomy or Cesarean section
• Pregnant or breastfeeding women
• Addiction or illness that prevent the person concerned from assessing the nature and scope of the clinical trial and its possible consequences
• indication that the participant is unlikely to comply with the trial protocoll (e.g. lack of compliance)
• official or court order for involuntary hospitalization

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Германия · 1 центр

• Department of Visceral, Thoracic and Vascular Surgery University Hospital Carl Gustav Caru — Dresden

Идентификаторы

NCT: NCT05652361 · TUD-COBOT2-087 · DE-25-00015527

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗