Health Condition 1: K918- Other intraoperative and postprocedural complications and disorders of digestive system
Conditions
Interventions
Intervention1: Intraoperative Perfusion Assessment Using Indocyanine Green (ICG) Fluorescence Imaging with Color-Segmented Fluorescence (CSF) Mode on the Stryker 1788/PINPOINT System: Participants und
Sponsors
Basavatarakam Indo-American Cancer Hospital and Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients undergoing procedures where perfusion matters colorectal resections, esophagectomy, gastric bypass, etc. 2. All elective gastrointestinal procedures with anastomosis are included 3. Have acceptable hematologic status total hemoglobin tHb more than or equal to 10 mg per dL 4. Patients more than or equal to 18 yrs of age 5. Patient provided a signed and dated informed consent 6. Willing to comply with study procedures and be available for the duration of the study 7. Ability to understand and the willingness to sign an IRB approved informed consent document
Exclusion criteria
Exclusion criteria: 1. Allergy of contraindication to ICG 2. Emergent surgeries Systemic or local infection 3. Any systemic anomaly during the pre-op assessment preventing patient participation in the study 4. Any febrile illness that precludes or delays participation preoperatively 5. Anything that would put the participant at increased risk or preclude compliance with the study 6. Any condition judged by the investigator to place the participant at unacceptable risk or confound results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pixel intensity values in intraoperative videos and images captured in CSF mode. Determine perfusion contrast ratio, brightest vs dimmest regions in the regions of interest ROI Number of cases with anastomosis or transection modified following visualization in CSF mode Proportion of cases where CSF visualization influenced surgical decisionsTimepoint: Intraoperative and Postoperative data collection | — |
Secondary
| Measure | Time frame |
|---|---|
| Mapping vascular arcade of mesentery of organ to be anastomosed: Recording of vascular anatomy of mesentery of organ to be anastomosed. Length of the marginal arcade from the nearest segmental vessel. Interobserver variability in CSF interpretation: CSF interpretation of de-identified still images from CSF mode by 3-5 surgeons on a 4-point perfusion scale. Average time to visualization: Interval (average; in seconds) from ICG injection to first clear visualization of the ROI Track rate of postoperative complications in relation to CSF perfusion assessments: Complication incidence at postoperative day 7 or day 15, day 30, & 6 months. Comparison of CSF ratings (such as excellent vs. fair ) vis a vis complication incidence (descriptive) at day 7 & day 30Timepoint: Postoperative POstoperative day 7, day 15, day 30, & 6 months | — |
Countries
India
Contacts
Public ContactSrijan Shukla
Basavatarakam Indo American Cancer Hospital & Research Institute
Outcome results
None listed