Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| DE-25-00015527 | Other Identifier | DMIDS |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| German Cancer Research Center | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Additional visualisation of surgical assistance during surgery | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additional visualisation of surgical assistance during surgery | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence 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 | 72 hours after Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Operating time [min] | Time from skin incision until placement of last skin staple/suture | During Surgery |
| Duration of postoperative hospital stay [days] | Postoperative day 1 until day of discharge |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marius Distler, Prof. Dr. | Contact | +49 351 458 4098 | marius.distler@ukdd.de | |
| Fiona Kolbinger, Dr. | Contact | +49 351 458 4098 | fiona.kolbinger@ukdd.de |
| Name | Affiliation | Role |
|---|---|---|
| Marius Distler, Prof. Dr. | University Hospital Carl Gustav Carus Dresden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Visceral, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden | Recruiting | Dresden | Saxony | 01307 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 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 | 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 | At day of discharge, assessed of up to 5 days |
| Assessment of the circumferential resection margin (CRM) | Rate of R0 resections | At day of discharge, assessed up to 5 days |
| Number of resected lymphnodes | Number of lymphnodes resected during surgery | 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). | 15 months |
| Rectal sphincter function before and after rectal resection | Sphincter function will be assessed by manometry preoperatively and 12 - 15 months postoperatively | 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 | 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 | Through study completion, an average of 6 months |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |