Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery (CoBot2)

Technische Universität Dresden

Status: Enrolling

Conditions: Rectum Cancer

Treatments: Other: Additional visualisation of surgical assistance during surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05652361

DE-25-00015527 (Other Identifier)

TUD-COBOT2-087

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Additional visualisation of surgical assistance during surgery

Experimental group

Treatment:

Other: Additional visualisation of surgical assistance during surgery