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

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.

Condition(s)Rectum Cancer
StatusRecruiting
PhaseNA
Study typeInterventional
SummaryThe 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.
Who can participateInclusion Criteria: * Patients with rectal cancer scheduled for robot-assisted rectal resection * Intact preoperative urogenital/rectal function * Full capability of consent Exclusion Criteria: * 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
Ages18 Years
SexAll
Lead sponsorTechnische Universität Dresden
LocationsDresden, Saxony, Germany
Start date2026-02
NCT IDNCT05652361
Official listinghttps://clinicaltrials.gov/study/NCT05652361

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