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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
12
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
Department of Visceral, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
Dresden, Saxony, Germany
RECRUITINGIncidence of discrepancies between the surgeon's preparation and the prediction of the CoBot system
System discrepancy score quantifying major misspecifications of the CoBot system in comparison to the surgeon's action
Time frame: 72 hours after Surgery
Operating time [min]
Time from skin incision until placement of last skin staple/suture
Time frame: During Surgery
Duration of postoperative hospital stay [days]
Postoperative day 1 until day of discharge
Time frame: At day of discharge, assessed up to 5 days
Duration of postoperative intermediate/intensive care unit stay [days]
Postoperative day 1 until day of discharge
Time frame: At day of discharge, assessed up to 5 days
Frequency of peri-operative morbidity after resection
Frequency of peri-operative complications after surgery until Day of Discharge
Time frame: At day of discharge, assessed of up to 5 days
Kind of peri-operative morbidity after resection
Kind of peri-operative complications after surgery until day of discharge
Time frame: At day of discharge, assessed of up to 5 days
Assessment of the circumferential resection margin (CRM)
Rate of R0 resections
Time frame: At day of discharge, assessed up to 5 days
Number of resected lymphnodes
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Number of lymphnodes resected during surgery
Time frame: During surgery
Assessment of pelvic function before and after rectal resection
Rectal function will be assessed preoperatively and 12-15 months postoperatively using the standard LARS score questionnaire, resulting in a score between 0 and 42. Higher scores mean a worse outcome (worse pelvic function).
Time frame: 15 months
Rectal sphincter function before and after rectal resection
Sphincter function will be assessed by manometry preoperatively and 12 - 15 months postoperatively
Time frame: 15 months
Assessment of the difficulty of the preparation
Surgeon questionnaire, the questionnaire qualitatively assesses nine items, each item scoring from "not at all" to "very much", evaluated individually
Time frame: 48 hours after surgery
Assessment of usability of guidance system
One-time final survey of all participating surgeons, the questionnaire qualitatively assesses nine items, each item scoring from "not at all" to "very much", evaluated individually
Time frame: Through study completion, an average of 6 months