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Development and Validation of an Artificial Intelligence-Based Assistance System for Function-Preserving Minimally-Invasive Rectal Cancer Surgery

Development and Validation of an Artificial Intelligence-Based Assistance System for Function-Preserving Minimally-Invasive Rectal Cancer Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00041023
Enrollment
250
Registered
2026-07-21
Start date
2026-10-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer

Interventions

Group 1: This is a non-interventional observational study. Retrospective and prospective data from routine clinical practice will be analyzed for patients who have undergone robot-assisted rectal rese

Sponsors

TU Dresden
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Retrospective: Robot-assisted rectal resections performed at a participating center Prospective: Indication for robot-assisted rectal resection using a surgical robot (e.g., the DaVinci system) Patient understands German

Exclusion criteria

Exclusion criteria: Conversion to open surgery Technical difficulties with data collection or data loss Missing or incomplete surgical videos

Design outcomes

Primary

MeasureTime frame
Intersection-over-Union (IoU) as a measure of the overlap between the actual location of a structure in the image (“ground truth”) and the location predicted by the AI model. Scale from 0 (no overlap) to 1 (perfect detection).

Secondary

MeasureTime frame
Additional metrics of predictive performance: F1 score, precision, recall, specificity, AUROC Qualitative endpoints: Assessment of AI-assisted detection of nerves and dissection planes by two surgeons, with evaluation of interrater agreement Technical performance parameters of the AI models: computation latencies, reliability, image distortions Functional outcomes (questionnaires): quality of life (QLQ-C30), fecal incontinence (LARS), urinary function (IPSS), female sexual function (FSFI), male erectile function (IIEF-5) Oncological endpoints: Local recurrence rate, overall survival, progression-free survival Surgical outcome parameters: Pathological quality of the specimen (CRM status, resection status), surgical complications, surgeons’ satisfaction with TME

Countries

Germany, Switzerland

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026