Rectum Cancer
Conditions
Keywords
Robotic Surgery, Total mesorectal excision
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.
Interventions
OTHERAdditional visualisation of surgical assistance during surgery
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
Sponsors
Technische Universität Dresden
German Cancer Research Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 5 days | Postoperative day 1 until day of discharge |
| Duration of postoperative intermediate/intensive care unit stay [days] | At day of discharge, assessed up to 5 days | Postoperative day 1 until day of discharge |
| Frequency of peri-operative morbidity after resection | At day of discharge, assessed of up to 5 days | Frequency of peri-operative complications after surgery until Day of Discharge |
| Kind of peri-operative morbidity after resection | At day of discharge, assessed of up to 5 days | Kind of peri-operative complications after surgery until day of discharge |
| Assessment of the circumferential resection margin (CRM) | At day of discharge, assessed up to 5 days | Rate of R0 resections |
| Number of resected lymphnodes | During surgery | Number of lymphnodes resected during surgery |
| Assessment of pelvic function before and after rectal resection | 15 months | 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). |
| Rectal sphincter function before and after rectal resection | 15 months | Sphincter function will be assessed by manometry preoperatively and 12 - 15 months postoperatively |
| 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 |
| Assessment of usability of guidance system | Through study completion, an average of 6 months | 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 |
Countries
Germany
Contacts
CONTACTMarius Distler, Prof. Dr.
CONTACTFiona Kolbinger, Dr.
PRINCIPAL_INVESTIGATORMarius Distler, Prof. Dr.
University Hospital Carl Gustav Carus Dresden
Outcome results
None listed