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The study aims to evaluate the use of the HyperSnap Surgical System (HSS1) during laparoscopic surgeries, specifically in bowel resections and cholecystectomies.
The study will observe patients undergoing bowel resection and cholecystectomy surgeries to determine if HyperSnap Surgical System (HSS1), as a primary visualisation tool, functions safely and capably as a laparoscopic imager. In addition, we will see if it subjectively improves the identification of critical anatomical structures. In addition, the study will secondarily assess how StO2 information may be included in the surgical workflow and how surgeons may react to this additional information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSS1 | Experimental | Surgery performed using HSS1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSS1 | Device | Surgery performed using HSS1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device safety | To demonstrate that under normal conditions of use, the performance characteristics of the device are those intended, enabling laparoscopic abdominal surgery to be safely performed using the UKCA-marked medical device (HSS1) as the primary surgical visualisation system. | From enrollment to end of follow up (30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Technological performance | To determine any undesirable side effects in technological performance and assess whether these constitute risks when weighed against the intended performance of the device. | Duration of surgery |
| Utility and usability of tissue oxygenation saturation maps in bowel surgery |
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Inclusion Criteria:
A) Cholelithiasis or cholecystitis with indications for laparoscopic surgery (cholecystectomy)
B) Colorectal cancer requiring elective bowel resection via a laparoscopic approach.
Exclusion Criteria:
A) Cholelithiasis or cholecystitis with indications for laparoscopic surgery (cholecystectomy)
B) Colorectal cancer requiring elective bowel resection via a laparoscopic approach.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Shapey, PhD FHEA FRCS | Contact | +44 20 7836 5454 | jonathan.shapey@kcl.ac.uk |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D002764 | Cholecystitis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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To assess the utility and usability of tissue oxygen saturation maps in bowel resection surgery for delineation of intestinal angiosomes and how the additional StO2 biomarker influenced clinical decision making |
| Duration of surgery |
| Utility and usability of tissue oxygenation saturation maps in cholecystectomy | To perform retrospective analysis of the utility and usability of tissue oxygen saturation maps in cholecystectomy (not shown during procedure) for delineation of relevant anatomical structures within the surgical field. | Duration of surgery |
| Human factors analysis on use of HSS1 | To perform a human factor analysis of the use of the UKCA marked medical device (HSS1) in relation to surgical workflow and surgeon performance. | Duration of surgery |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |