Cholecystectomy, Laparoscopic, Cholecystitis, Colorectal Neoplasms, Colorectal Surgery
Conditions
Keywords
hyperspectral imaging, surgery, laparoscopic surgery, colorectal cancer, cholecystitis
Brief summary
The study aims to evaluate the use of the HyperSnap Surgical System (HSS1) during laparoscopic surgeries, specifically in bowel resections and cholecystectomies.
Detailed description
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.
Interventions
DEVICEHSS1
Surgery performed using HSS1
Sponsors
King's College London
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
A) Cholelithiasis or cholecystitis with indications for laparoscopic surgery (cholecystectomy) * Adult patients aged 18 years and over * Common bile duct diameter \< 8mm as assessed using ultrasound * Patients able to provide written informed consent B) Colorectal cancer requiring elective bowel resection via a laparoscopic approach. * Adult patients aged 18 years and over * Patients who are scheduled for elective laparoscopic colon cancer resection * Patients able to provide written informed consent
Exclusion criteria
A) Cholelithiasis or cholecystitis with indications for laparoscopic surgery (cholecystectomy) * Patients under 18 years of age * Patients with a history of previous abdominal surgery and multiply scarred abdomen * Common bile duct diameter ≥ 8mm as assessed using ultrasound * Patients unable to provide written informed consent * Patients who are pregnant B) Colorectal cancer requiring elective bowel resection via a laparoscopic approach. * Patients under 18 years of age * Patients with a history of previous abdominal surgery and multiply scarred abdomen * Patients unable to provide written informed consent * Patients undergoing emergency surgery * Patients who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device safety | From enrollment to end of follow up (30 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technological performance | Duration of surgery | To determine any undesirable side effects in technological performance and assess whether these constitute risks when weighed against the intended performance of the device. |
| Utility and usability of tissue oxygenation saturation maps in bowel surgery | Duration of surgery | 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 |
| Utility and usability of tissue oxygenation saturation maps in cholecystectomy | Duration of surgery | 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. |
| Human factors analysis on use of HSS1 | Duration of surgery | To perform a human factor analysis of the use of the UKCA marked medical device (HSS1) in relation to surgical workflow and surgeon performance. |
Contacts
Primary ContactJonathan Shapey, PhD FHEA FRCS
Outcome results
None listed