Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery
- Conditions
- Rectum Cancer
- Interventions
- Other: Additional visualisation of surgical assistance during surgery
- Registration Number
- NCT05652361
- Lead Sponsor
- Technische Universität Dresden
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Patients with rectal cancer scheduled for robot-assisted rectal resection
- Intact preoperative urogenital/rectal function
- Full capability of consent
- Previous/Second malignant disease <5 years before diagnosis of rectal cancer
- Previous abdominal surgery, except for appendectomy, cholecystectomy or Cesarean section
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Additional visualisation of surgical assistance during surgery Additional visualisation of surgical assistance during surgery -
- Primary Outcome Measures
Name Time Method Incidence of discrepancies between the surgeon's preparation and the prediction of the CoBot system 72 hours after Surgery System discrepancy score quantifying major misspecifications of the CoBot system in comparison to the surgeon's action
- Secondary Outcome Measures
Name Time Method Operating time [min] During Surgery Time from skin incision until placement of last skin staple/suture
Duration of postoperative hospital stay [days] At day of discharge, assessed up to 90 days Postoperative day 1 until day of discharge
Assessment of the difficulty of the preparation 48 hours after surgery Surgeon questionnaire, the questionnaire qualitatively assesses nine items, each item scoring from "not at all" to "very much", evaluated individually
Duration of postoperative intermediate/intensive care unit stay [days] At day of discharge, assessed up to 90 days Postoperative day 1 until day of discharge
Frequency of peri-operative morbidity after resection 24 months Frequency of peri-operative complications after surgery
Assessment of usability of guidance system 48 hours after surgery Surgeon questionnaire, the questionnaire qualitatively assesses nine items, each item scoring from "not at all" to "very much", evaluated individually
Assessment of pelvic function before and after rectal resection 24 months Rectal and urogenital function will be assessed preoperatively and 12-24 months postoperatively using the PERIFUNC score questionnaire, resulting in a score between 0 and 120. Higher scores mean a worse outcome (worse pelvic function).
Rectal sphincter function before and after rectal resection 24 months Sphincter function will be assessed by manometry preoperatively and 12 - 24 months postoperatively
Kind of peri-operative morbidity after resection 24 months Kind of peri-operative complications after surgery
Assessment of oncological outcomes: Frequency of Overall survival (OS) 24 months The overall survival of all patients is assessed between operation date to date of death of any cause
Assessment of oncological outcomes: Frequency of Progression Free survival (PFS) 24 months The progression free survival of all patients is assessed between operation date to date of tumor progression
Assessment of oncological outcomes: Frequency of Loco-Regional Tumor Free Survival (LRFS) 24 months The Loco-Regional Tumor Free Survival of all patients is assessed between operation date to date of local tumor relapse
Trial Locations
- Locations (1)
Department of Visceral, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
🇩🇪Dresden, Saxony, Germany